CORE DYNAMICS CD801Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 20653405043277), received between Aug 12, 2024 and Jan 7, 2026 — classified as 4 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (16 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026Detachment of Device or Device Component

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE CD801, 5MM LAPAROSCOPIC KITTNER, BLUNT DISSECTOR 40 CM LENGTH DEVICE WAS USED IN AN UNNAMED PROCEDURE ON (B)(6) 2025 AND, ¿IN SOME CASES, THE WHITE PAD IS NOT ATTACHED TO THE INSTRUMENT WHEN THE ENVELOPE IS CLOSED, AND IN OTHER CASES DURING THE PROCEDURE, AND COMES OFF VERY EASILY.¿. FURTHER ASSESSMENT FOUND ¿IT ALMOST ALWAYS HAPPENED BEFORE INSERTING THE INSTRUMENT INTO THE TROCAR.¿. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23990227 ↗
• MalfunctionJan 7, 2026Detachment of Device or Device Component

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE CD801, 5MM LAPAROSCOPIC KITTNER, BLUNT DISSECTOR 40 CM LENGTH DEVICE WAS USED IN AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND, ¿IN SOME CASES, THE WHITE PAD IS NOT ATTACHED TO THE INSTRUMENT WHEN THE ENVELOPE IS CLOSED, AND IN OTHER CASES DURING THE PROCEDURE, AND COMES OFF VERY EASILY.¿. FURTHER ASSESSMENT FOUND ¿IT ALMOST ALWAYS HAPPENED BEFORE INSERTING THE INSTRUMENT INTO THE TROCAR.¿. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23990225 ↗
• MalfunctionJan 7, 2026Detachment of Device or Device Component

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE CD801, 5MM LAPAROSCOPIC KITTNER, BLUNT DISSECTOR 40 CM LENGTH DEVICE WAS USED IN AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND, ¿IN SOME CASES, THE WHITE PAD IS NOT ATTACHED TO THE INSTRUMENT WHEN THE ENVELOPE IS CLOSED, AND IN OTHER CASES DURING THE PROCEDURE, AND COMES OFF VERY EASILY.¿ FURTHER ASSESSMENT FOUND ¿IT ALMOST ALWAYS HAPPENED BEFORE INSERTING THE INSTRUMENT INTO THE TROCAR.¿ THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23990204 ↗
• MalfunctionJan 7, 2026Detachment of Device or Device Component

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE CD801, 5MM LAPAROSCOPIC KITTNER, BLUNT DISSECTOR 40 CM LENGTH DEVICE WAS USED IN AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND, ¿IN SOME CASES, THE WHITE PAD IS NOT ATTACHED TO THE INSTRUMENT WHEN THE ENVELOPE IS CLOSED, AND IN OTHER CASES DURING THE PROCEDURE, AND COMES OFF VERY EASILY.¿ FURTHER ASSESSMENT FOUND ¿IT ALMOST ALWAYS HAPPENED BEFORE INSERTING THE INSTRUMENT INTO THE TROCAR.¿ THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23990183 ↗
• MalfunctionJan 5, 2026Detachment of Device or Device Component

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE CD801, 5MM LAPAROSCOPIC KITTNER, BLUNT DISSECTOR 40 CM LENGTH DEVICE WAS USED IN AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND, ¿IN SOME CASES, THE WHITE PAD IS NOT ATTACHED TO THE INSTRUMENT WHEN THE ENVELOPE IS CLOSED, AND IN OTHER CASES DURING THE PROCEDURE, AND COMES OFF VERY EASILY.¿. FURTHER ASSESSMENT FOUND ¿IT ALMOST ALWAYS HAPPENED BEFORE INSERTING THE INSTRUMENT INTO THE TROCAR. ONLY ONE CASE THE SWAB FELL IN THE ABDOMEN. WITH A LOT OF PATIENCE THEN RECOVERED.¿. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23963761 ↗
• MalfunctionDec 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT, IN A NON-SURGICAL EVENT ON 10DEC25, THE CD801, 5MM LAPAROSCOPIC KITTNER, BLUNT DISSECTOR 40 CM LENGTH DEVICE WAS DESCRIBED AS: ¿WITH THE ENVELOPE SEALED, IT IS OBSERVED THAT THE SWAB DOES NOT REMAIN IN PLACE AND APPEARS DETACHED FROM THE INSTRUMENT.¿. THERE WAS NO IMPACT OR INJURY TO ANY PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23932880 ↗
• MalfunctionDec 17, 2025Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, CD801, 5MM LAPAROSCOPIC KITTNER, BLUNT DISSECTOR 40 CM LEN WAS BEING USED ON (B)(6) 2025 AND "DURING THE MINIMALLY INVASIVE SURGERY, THE TIP OF THE SWARBOR BECAME DETACHED AND REMAINED IN THE PATIENT'S CHEST. IT WAS THEREFORE NECESSARY TO INSPECTION THE SURGICAL SITE AND REMOVE THE PIECE. THIS CAUSED NO HARM TO THE PATIENT BUT IT EXPOSED THE POTENTIAL ERROR OF INSTRUMENT RETENTION AT THE SURGERY SITE.¿ THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828700 ↗
• MalfunctionDec 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE DEVICE, CD801, 5MM LAPAROSCOPIC KITTNER, BLUNT DISSECTOR 40 CM LENGTH WAS BEING USED ON (B)(6) 2025 AND "DURING LAPAROSCOPIC CHOLECYSTECTOMY, SURGEON NOTICED TIP OF KITTNER CAME OFF OF HANDLE AND WAS IN ABDOMINAL CAVITY. LOOSE TIP OF KITTNER REMOVED FROM PATIENT'S ABDOMINAL CAVITY.¿ THERE WAS NO REPORT OF IMPACT OR INJURY TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ¿ANOTHER KITTNER WITH A DIFFERENT LOT NUMBER¿. THERE WAS A 5-MINUTE DELAY. THE PATIENT¿S OUTCOME STATUS WAS REPORTED AS ¿GOOD¿. PER INFORMATION RECEIVED WITH THE DEVICE RETURN "TIP FELL OFF AS SOON AS KITTNER INSERTED INTO TROCAR." THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23703798 ↗
• MalfunctionOct 27, 2025Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT THE THAT THE CD801, 5MM LAPAROSCOPIC KITTNER, BLUNT DISSECTOR 40 CM LENGTH DEVICE WAS BEING USED DURING A LAPAROSCOPIC NEPHRECTOMY PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED ¿EASY DETACHMENT OF THE UPPER PART OF THE LAPAROSCOPIC KITTNER DURING USE.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT ¿WHEN THEY CLEANED CD801 (OUTSIDE THE PATIENT) THE UPPER PART DETACHED.¿. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THE CURRENT STATE OF THE PATIENT WAS REPORTED AS ¿NO PROBLEM¿. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23391489 ↗
• MalfunctionSep 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE CD801 5MM LAPAROSCOPIC KITTNER, BLUNT DISSECTOR 40 CM LENGTH WAS BEING USED ON (B)(6) 2025 AND ¿DURING THE PROCEDURE THE TIP OF THE ENDO KITTNER (THE SPONGE PORTION) FELL OFF INTO THE PATIENT'S ABDOMEN. NO EXCESSIVE FORCE WAS USED; THE SPONGE FELL OFF WITH EASE.¿ PER FURTHER ASSESSMENT IT WAS REPORTED THAT THE TIP FELL INTO THE SURGICAL SITE AND WAS RETRIEVED. THERE WAS NO IMPACT OR INJURY TO THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23154194 ↗
• MalfunctionAug 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDSUN REPORT (B)(4) RECEIVED ON 28JUL25. A SEARCH OF THE COMPLAINT SYSTEM HAS NOT FOUND A COMPLAINT REPORTED FOR THIS DEVICE DURING THIS TIMEFRAME. THE REPORT WAS FOUND TO BE WRITTEN AGAINST THE CD801, 5MM LAPAROSCOPIC KITTNER, BLUNT DISSECTOR. THE INCIDENT OCCURRED SOMETIME IN MAY OF 2025. THE REPORT STATES THAT "DURING LAPAROSCOPIC CHOLECYSTECTOMY IT WAS NOTICED BY RESIDENT THAT THE TIP OF KITTNER WAS MISSING. THE DOCTOR WAS ABLE TO FIND AND RETRIEVE THE TIP FROM THE PATIENT ABDOMEN." THERE WAS NO IMPACT OR INJURY TO THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22814459 ↗
• MalfunctionJul 22, 2025Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, CD801, 5MM LAPAROSCOPIC KITTNER, BLUNT DISSECTOR 40 CM LENGTH, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND WHEN IT WAS REPORTED, ¿THE COTTON SWAB AT THE END OF THE DEVICE IS REMOVED FROM ITS HOUSING WITH EASE AFTER A SHORT TIME.¿ FURTHER ASSESSMENT QUESTIONING WAS SENT TO THE REPORTER TO DEFINE FURTHER THE NATURE OF THE INCIDENT; HOWEVER, TO DATE CONMED HAS NOT RECEIVED A RESPONSE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563613 ↗
• MalfunctionMay 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT A CD801, 5MM LAPAROSCOPIC KITTNER, BLUNT DISSECTOR 40 CM LENGTH DEVICE WAS USED IN AN UNKNOWN SURGICAL PROCEDURE ON APPROXIMATELY (B)(6) 2025 , AND ¿THE TIP FELL OFF AFTER USE POST OP¿. THERE WAS NO INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT WAS ATTEMPTED, AND A GOOD FAITH EFFORT WAS MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED TO DATE. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22051242 ↗
• InjuryApr 24, 2025Material Fragmentation; Material Fragmentation

  THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF MEDSUN REPORT NO. (B)(4), RECEIVED ON 16APR25. A SEARCH OF THE COMPLAINT SYSTEM HAS NOT FOUND A COMPLAINT REPORTED FOR THIS DEVICE/LOT NUMBER DURING THIS TIMEFRAME. THE REPORT WAS FOUND TO BE WRITTEN AGAINST THE CD801, 5MM LAPAROSCOPIC KITTNER, BLUNT DISSECTOR 40 CM LENGTH. THIS WAS REPORTED AS A PRODUCT PROBLEM NOT AN ADVERSE EVENT. THE REPORT STATES THAT THE CD801, 5 MM LAPAROSCOPIC KITTNER, BLUNT DISSECTOR 40 CM LENGTH DEVICE WAS USED IN A SURGICAL PROCEDURE IN (B)(6) 2025, AND "DURING THE LAPAROSCOPIC PORTION OF THIS PROCEDURE - LAPAROSCOPIC CONVERTED TO OPEN SIGMOIDECTOMY WITH PRIMARY ANASTOMOSIS AND CLOSURE OF COLOVESICALS FISTULA - THE SURGEON WAS USING A 5 MM LAPAROSCOPIC KITTNER FOR DISSECTION AND THE TIP OF THE KITTNER BROKE OFF. THE TIP WAS RETRIEVED, AND ALL PARTS OF THE DEVICE WERE ACCOUNTED FOR. A SECOND DEVICE WAS PUT INTO USE AND THE TIP OF THAT KITTNER BENT BUT REMAINED INTACT". FURTHER ASSESSMENT FOUND THE PATIENT'S CURRENT STATUS AS "DISCHARGED HOME WITH HOME HEALTH AGENCY", AND A POST-OPEARTIVE DIAGNOSIS OF "COMPLICATED DIVERTICULITIS WITH COLOVESICAL FISTULA AND INFLAMMATORY ADHESIONS". THERE IS NO REPORT OF FURT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21899278 ↗
• MalfunctionFeb 28, 2025Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, (B)(6), 5MM LAPAROSCOPIC KITTNER, BLUNT DISSECTOR 40 CM LENGTH, WAS BEING USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿THIS PAST WEEKEND WE HAD TWO 5MM LAP KITTNERS (REF# (B)(4)) FALL APART DURING THE SURGERY. WE SAVED THE ITEM AND THE PACKAGING.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THERE WAS NO REPORT OF FRAGMENTATION CONTACT WITH THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT ANY DELAY BEING REPORTED. THE PATIENT WAS DISCHARGED AS PLANNED. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21490199 ↗
• MalfunctionFeb 28, 2025Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, CD801, 5MM LAPAROSCOPIC KITTNER, BLUNT DISSECTOR 40 CM LENGTH, WAS BEING USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿THIS PAST WEEKEND WE HAD TWO 5MM LAP KITTNERS (REF# (B)(4)) FALL APART DURING THE SURGERY. WE SAVED THE ITEM AND THE PACKAGING.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THERE WAS NO REPORT OF FRAGMENTATION CONTACT WITH THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT ANY DELAY BEING REPORTED. THE PATIENT WAS DISCHARGED AS PLANNED. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21490198 ↗
• InjuryFeb 18, 2025Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE CD801, 5MM LAPAROSCOPIC KITTNER, BLUNT DISSECTOR 40 WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6)2024 WHEN IT WAS REPORTED ¿THE SPONGE FALLS OFF THE TIP OF THE LAPAROSCOPIC KITTNER AND INTO THE PATIENT. FURTHER ASSESSMENT QUESTIONS WERE REQUESTED OF THE REPORTER AND A GOOD FAITH EFFORT WAS COMPLETED; HOWEVER, THE REPORTER HAS NOT RESPONDED TO OUR ATTEMPTS FOR INFORMATION. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE TO THE POSSIBILITY OF THE PATIENT RETAINING A FOREIGN BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21396410 ↗
• MalfunctionJan 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE DEVICE, CD801, 5MM LAPAROSCOPIC KITTNER, BLUNT DISSECTOR 40 CM LENGTH, WAS BEING OPENED FOR AN UNKNOWN PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿WHEN OPENING THE DEVICE, THE WHITE PAD DETACHES.¿. THERE WAS NO REPORT OF PATIENT INVOLVEMENT; THEREFORE, THERE WAS NO INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION TO BE REPORTED. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21251235 ↗
• MalfunctionDec 20, 2024Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT THE CD801, 5MM LAPAROSCOPIC KITTNER, BLUNT DISSECTOR 40 CM LENGTH, DEVICE WAS BEING USED IN A LAPAROSCOPIC NEPHRECTOMY PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿WE HAVE HAD ANOTHER 2 KITTNERS THAT HAVE BOTH COME APART AND THE END HAS HAD TO BE RETRIEVED FROM THE PATIENT.¿. IT WAS ALSO CONFIRMED THAT BOTH OF THESE KITTNERS WERE USED IN THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20990212 ↗
• InjuryNov 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE CD801, 5MM LAPAROSCOPIC KITTNER, BLUNT DISSECTOR 40 CM LENGTH, DEVICE WAS BEING USED ON AN UNKNOWN DATE DURING A LAPAROSCOPIC PROCEDURE WHEN IT WAS REPORTED THE SWAB END OF THE KITTNER CAME OFF INSIDE THE PATIENT DURING LAPAROSCOPY AND HAD TO BE RETRIEVED. THIS WAS DURING BLUNT DISSECTION AND NO OTHER INSTRUMENT WAS INVOLVED IT APPEARED JUST TO DISLODGE. WE DID HAVE TO CONVERT TO AN OPEN PROCEDURE DUE TO BLEEDING LATER ON IN THE SURGERY.". FURTHER ASSESSMENT QUESTIONING FOUND THAT ¿SURGEON HAS CONFIRMED BLEEDING IS NOT BECAUSE OF THE KITTNER COMING APART. IT IS HOWEVER RELEVANT TO THE OVERALL RISK.". IT WAS ALSO CONFIRMED THAT THERE WAS NO INFECTION PRESENT IN THE PATIENT.¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER KITTNER. THERE WAS NO REPORT OF EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON REPORTED INJURY DUE TO CONVERTING FROM A LAPAROSCOPIC PROCEDURE TO AN OPEN PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20722335 ↗
• MalfunctionOct 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE CD801, 5MM LAPAROSCOPIC KITTNER, BLUNT DISSECTOR 40 CM LENGTH WAS BEING USED ON (B)(6)2024 DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE WHEN IT WAS REPORTED ¿DURING A LAPAROSCOPIC CHOLECYSTECTOMY THE TIP OF THE KITTNER FELL OFF AND WAS RETRIEVED INSIDE THE ABDOMINAL CAVITY. IT WAS SUCCESSFULLY REMOVED.¿. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20450728 ↗
• MalfunctionOct 14, 2024Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE CD801, 5MM LAPAROSCOPIC KITTNER, BLUNT DISSECTOR 40 CM LENGTH DEVICE WAS BEING USED IN AN UNKNOWN PROCEDURE ON 18SEP24, WHEN IT WAS REPORTED ¿CONMED LAP KITTNER DISSECTOR (LOT# 202405061) IS FALLING APART INSIDE THE ABDOMEN. WE OPENED TWO MORE WITH DIFFERENT LOTS AND THEY SEEM TO BE FINE.¿. FURTHER ASSESSMENT WAS SENT, AND A GOOD FAITH EFFORT WAS MADE TO OBTAIN FURTHER INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED TO DATE. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT. THIS REPORT IS BEING RAISED ON REPORTED INJURY DUE TO THE POSSIBILITY OF THE PATIENT RETAINING A FOREIGN BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20443336 ↗
• MalfunctionSep 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, CD801, 5MM LAPAROSCOPIC KITTNER, BLUNT DISSECTOR 40 CM LENGTH, WAS BEING PRE-OP TESTED PRIOR TO AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿WAS NOT USED IN SURGERY AS SURGEON PULLED THE TIPS OFF OF THE KITTNER AND DECIDED NOT TO USE THE ITEM.". THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20299878 ↗
• InjurySep 24, 2024Material Fragmentation; Material Fragmentation

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE CD801, 5MM LAPAROSCOPIC KITTNER, BLUNT DISSECTOR 40 CM LENGTH DEVICE WAS BEING USED DURING A LAPAROSCOPIC EXPLORATION FOR INFECTION / LYSIS OF ADHESIONS PROCEDURE ON (B)(6) 2024, AND ¿DEFECTIVE KITTNERS FELL OFF IN MID-SURGERY¿. THERE WAS A SEARCH FOR THE MISSING KITTNERS. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE AND WITH A DELAY OF 20 MINUTES. FURTHER ASSESSMENT FOUND THAT A FRAGMENT OR COMPONENT FELL INTO THE SURGICAL SITE, AND THE SURGICAL TEAM WAS "UNABLE TO FIND" THEM; THEREFORE, ALL FRAGMENTS OR COMPONENTS WERE NOT RETRIEVED. THERE WAS NO MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT, AND THE PATIENT'S CONDITION IS "STABLE". THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE RETAINED FOREIGN BODY, AS ALL FRAGMENTS OR COMPONENTS COULD NOT BE FOUND AFTER FALLING INTO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20290337 ↗
• MalfunctionSep 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS COMPLAINT WAS CREATED BY THE FINDING OF MAUDE REPORT NUMBER (B)(4). THE ACCOUNT AND CONTACT INFORMATION FOR THIS REPORT ARE NOT KNOWN. THE CURRENT COMPLAINT DATABASE HAS BEEN RESEARCHED FOR THIS EVENT AND THERE WERE NO FINDINGS. THE CD801, 5 MM LAPAROSCOPIC KITTNER, BLUNT DISSECTOR 40 CM LENGTH WAS BEING USED ON (B)(6) 2024 AND "DURING THE LAP CHOLE THE SPONGE ON THE LAPAROSCOPIC KITTNER FELL OFF THE APPLICATOR.THE SURGEON NOTICED THIS RIGHT AWAY AND RETRIEVED THE SPONGE.THE NEEDS TO BE REPORTED AS A FACTORY DEFECT". THIS WAS REPORTED AS A PRODUCT PROBLEM NOT AN ADVERSE EVENT. THERE WAS NO IMPACT OR INJURY TO THE PATIENT "NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS". DUE TO THE REPORTER BEING ANONYMOUS CONMED IS UNABLE TO REQUEST FURTHER INFORMATION. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20248773 ↗