Kii Sleeve CFS22Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00607915117740), received between Feb 10, 2016 and Feb 20, 2026 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (11 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionFeb 20, 2026Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC SIGMOIDECTOMY EVENT DESCRIPTION: THE CONSULTANT NOTICED A CLEAR PLASTIC RING INSIDE THE PATIENT UPON HIS FINAL CHECK BEFORE CLOSING UP, HE DID NOT NOTICE WHEN THIS MAY HAVE COME LOSE, THEREFORE IT IS NOT CLEAR WHEN THE INCIDENT OCCURED. HE DID NOTICE THAT THE TROCAR WAS POTENTIALLY LEAKING GAS WHILST INSTRUMENTS WERE INSIDE IT TOWARDS THE LATTER END OF THE SURGERY HOWEVER DID NOT REPLACE IT. ADDITIONAL INFORMATION RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 05FEB26: NO PHOTOS/VIDEOS AVAILABLE. THE ENTIRE COMPONENT HAS FALLEN OUT AS A WHOLE. ALL THE PIECES WERE RETRIEVED FROM THE PATIENT. NO INTERNAL SEAL COMPONENTS REMOVED OR CUT IN ORDER TO INSPECT THE DAMAGED COMPONENT. INSTRUMENTATION THAT PASSED THROUGH THE EVENT UNIT: STAPLER, HARMONIC ENERGY DEVICE, GRASPER, SWABS, SUCTION. INTERVENTION: NOT APPLICABLE, IT WAS AT END OF THE SURGERY SO THEY DID NOT REPLACE IT. PATIENT STATUS: PATIENT IS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402788 ↗
• MalfunctionJan 21, 2026Material Fragmentation

  PROCEDURE PERFORMED: BILATERAL LASH WITH SALPINGECTOMY. EVENT DESCRIPTION: INFORMATION RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE, VIA PATIENT COMPLAINT FORM, ON 07JAN2026: [TRANSLATION] DURING A BILATERAL SALPINGECTOMY ON (B)(6) 2025, THE FOLLOWING SITUATION OCCURRED: WHEN INSERTING THE MORCELLATOR TO REMOVE THE SPECIMEN, THE MORCELLATOR SPIKE TOUCHED THE UMBILICAL TROCAR THROUGH WHICH THE LAPAROSCOPE WAS INSERTED. (A.E. DUE TO A MATERIAL DEFECT) THE PLASTIC BROKE INTRAOPERATIVELY, CAUSING A SMALL DEFECT IN THE TROCAR. ADDITIONAL INFORMATION RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE, VIA EMAIL, ON 16JAN2026: NO ADDITIONAL INFORMATION BESIDES PRODUCT IS RETURNING. PATIENT STATUS: NO PATIENT INJURY NOR ILLNESS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24133734 ↗
• MalfunctionJan 7, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: DIAGNOSTIC LAP AND WASHOUT. EVENT DESCRIPTION: WE ARE CONTACTING ON BEHALF OF THE GYNAECOLOGY TEAM AT [HOSPITAL NAME] TO ALERT YOU TO A DISTRESSING INCIDENT WHERE PART OF YOUR CANNULA (KII SLEEVE - CFS22, LOT 1524049) BROKE DURING OUR LAPAROSCOPIC PROCEDURE AND SMALL FRAGMENT REMAINED IN THE ABDOMEN OF A PATIENT. WE WERE UNABLE TO LOCATE THIS DESPITE SIGNIFICANT EFFORTS. WE WOULD LIKE YOU TO BE AWARE FOR YOUR OWN INVESTIGATIONS AND QUALITY ASSURANCE. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21093297 ↗
• MalfunctionAug 2, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED NA (INCOMING INSPECTION) DETAILED DESCRIPTION OF EVENT: [DISTRIBUTOR] INCOMING INSPECTION PO #24007 THIS IS A COMPLAINT FROM [DISTRIBUTOR] EVALUATION TEAM. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: (B)(6)2023 PLEASE REFER TO THE ATTACHMENT FILE. WE FOUND DEFECTS AS THE RESULT OF INCOMING INSPECTION OF THE PRODUCTS. PLEASE REFER TO THE ATTACHMENT MATERIAL FOR THE QUANTITY WHICH RETURNS THE PRODUCTS. WE FOUND THE DEFECTS THAT ALREADY INFORMED APPLIED MEDICAL BY CER. WE JUST INFORM YOU THE DEFECT AND RETURN THE PRODUCTS FOR FOLLOWING DEFECTS. YOU DO NOT NEED INVESTIGATION. HAIRLIKE OBJECT IN POUCH - CFS22 LOT #1487235 (1 EA.). PATIENT STATUS: NA (NO PATIENT INVOLVEMENT). TYPE OF INTERVENTION: NA (INCOMING INSPECTION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17440070 ↗
• MalfunctionOct 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIE INTERVENTIONNEL AND CHROMOPERTURBATION EVENT DESCRIPTION: THE VALVA WAS DAMAGED DURING THE PROCEDURE. PIECES OF VALVA FELT INTO THE ABDOMINAL CAVITY. NO POSSIBILITY TO TAKE BACK THE DAMAGED DEVICE: THERE IS PARTICULAR RULE IN GRAND DUCHY OF LUXEMBURG. HOSPITAL HAVE TO SEND THE DAMAGED DEVICE TO LUXEMBURGER REGULATION FOR A NATIONAL ANALYZE AND MATERIOVIGILENCE EXPERTISE. PATIENT STATUS: NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15667801 ↗
• MalfunctionOct 10, 2022Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAP NEPHRECTOMY. EVENT DESCRIPTION: WE HAVE EXPERIENCED A PATIENT SAFETY INCIDENT WITH THE KII 12MM SLEEVE, WHERE THE PLASTIC TIP OF THE PORT SNAPPED OFF AND RETAINED INSIDE THE PATIENT. WE WERE UNABLE TO RETRIEVE THE PIECE OF PLASTIC FROM INSIDE THE PATIENT. ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 26OCT22: NO EFFECTS ON THE PATIENT AT ALL. NO CONCERN FROM SURGEON. NO FOLLOW UP NEEDED. NAME OF PROCEDURE BEING PERFORMED WAS LAP NEPHRECTOMY. TROCAR REMOVED AND NOTED THERE WAS A PIECE MISSING. TRIED TO LOCATE BUT WASN¿T FOUND. TROCAR WAS INSERTED BY EXPERIENCED CONSULTANT USING THE DEVICE AS HE ALWAYS HAS. TWISTING AND PUSHING. NO DIFFICULTY DURING INSERTION. THE BREAK WAS NOT CONSIDERED A CLEAN BREAK. IT WAS PARTIALLY BROKEN AT THE RIM OF THE TIP. ROUGHLY 4MM LENGTH AND 2MM DIAMETER. THIS TROCAR WAS NOT USED WITH A ROBOT. FAN RETRACTOR WAS INSIDE THE CANNULA AT THE TIME OF THE INCIDENT. DESCRIPTION OF INCIDENT: FAN RETRACTOR BROKEN DURING THE SURGERY, THERE WAS PRESSURE BEING APPLIED TO USE THE FR WHICH IS TO BELIEVED TO HAVE CAUSED THE FR TO BREAK. ONCE THIS WAS REMOVED AND THE TROCAR WAS REMOVED. ONLY THEN WAS THE TROCAR END

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15569877 ↗
• MalfunctionAug 23, 2022Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: WHILE INSERTING THE TROCAR (WITHOUT OBTURATOR) THROUGH MINILAP INCISION, PIECES OF PLASTIC FELL INTO THE ABDOMEN. THE STAFF IS UNSURE IF ALL THE FRAGMENTS HAVE BEEN SECURED. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15279965 ↗
• MalfunctionAug 23, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: "LAPAROSCOPIC PROSTATECTOMY" EVENT DESCRIPTION: " THIS IS A COMPLAINT FROM THE MARKET. ADMINISTRATIVE NO. (B)(4). PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION." "SEPTUM DAMAGED" "REPORT FROM THE SALES REP THE DOCTOR NOTED A BLACK FRAGMENT INSIDE ABDOMINAL CAVITY IN THE FIELD OF VIEW OF A SCOPE CAMERA. AS THE RESULT OF INSPECTING THE DEVICES POTENTIALLY CAUSED THE INCIDENT, HE/SHE CONFIRMED THAT A PORTION OF THE SEPTUM WAS FRAGMENTED. IT WAS ASSUMED THAT THE INCIDENT CAUSED DURING MANIPULATING A FORCEPS. LAPAROSCOPIC PROSTATECTOMY PROCEDURE WAS PERFORMED. THE FRAGMENT WAS REMOVED, THE TROCAR WAS REPLACED WITH NEW ONE AND THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY AND LESS BLEEDING. IT WAS REPORTED THAT THE DOCTOR HAD A SIGN OF ROUGHLY HANDLING SOME DEVICES INSIDE THE TROCAR. THE NUMBER OF INSERTED DEVICES INTO THE TROCAR WAS LARGE. THE CER CHECK LIST IS UNAVAILABLE. INITIAL INVESTIGATION REPORT THE EVENT UNIT WAS RETURNED TO US AND VISUALLY INSPECTED. THE SEPTUM WAS FRAGMENTED(FIG.1). THE RETURNED FRAGMENT SIZE WAS APPROX.. 8.0MM X 5.5MM. THE FRAGMENT MATCHED THE MISSING PORTION ON THE SEPTUM IN SHAPE(FIG.2). HOWEVER, WE NOTED A MISSING PORTION ON T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6813840 ↗
• MalfunctionMay 3, 2017Fracture; Fracture

  THIS CER IS CREATED FOR A STERILE PRODUCT RETURNED FROM (B)(4) (REFERENCE MDR# 2027111-2017-01348). INCIDENT DESCRIPTION FOR (B)(4): NACH DEM CER TEIL 1 HABE ICH PERSÖNLICH DIESE CHARGE GEPRÜFT, UND LEIDER IST DIE TROKARHÜLSE BEI LEICHTEM DRUCK ZWISCHEN DAUMEN UND ZEIGEFINGER AM UNTEREN ENDE UNTER DEM BALLON GEBROCHEN. DER KUNDE MÖCHTE SOMIT AUCH DIESE TROKARE ZURÜCK SCHICKEN UND ERSATZ HABEN. DER KUNDE MÖCHTE DEN BERICHT DIREKT. TRANSLION MATTHIAS HIPPLER: AFTER THE FIRST ISSUE, DANA TESTED A STERILE PRODUCT FROM THE SAME LOT NO WITH THE SAME RESULT. WITH A SOFT PRESSURE BETWEEN THUMB AND INDEX FINGER THE DISTAL PART OF CANNULA NEAR THE BALLOON WAS BROKEN. THE CUSTOMER WANTS TO SWAP OUT THE COMPLETE STOCK OF THIS LOT NO. THE CUSTOMER IS ASKING FOR A DIRECT FULL REPORT. PATIENT STATUS: NA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6540298 ↗
• MalfunctionMar 2, 2017Material Fragmentation; Material Fragmentation

  LAP ANTERIOR. COLON RESECTION. (B)(6). -" NEARLY FINISHING THE PROCEDURE, WHEN THE SURGEON SEES A CLACK "RUBBER" SPOT INTRAABDONIMAL. NOTHING IS MISSING ON INSTRUMENTS. GUESS IT MIGHT BE A PIECE OF A TROCAR SEAL- BUT NOT SURE." PATIENT STATUS - PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6375129 ↗
• MalfunctionMar 1, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED UNKNOWN:"THIS IS A COMPLAINT FROM THE MARKET FROM THE MARKET. (B)(4). THE DEFECT UNIT AND A FRAGMENT WILL BE RETURNED TO AMR. PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION. THE PHYSICIAN NOTICED A BLACK FRAGMENT INSIDE THE BODY CAVITY. THE SEPTUM WAS FOUND TO BE BROKEN. NO DAMAGE WAS OBSERVED ON THE FORCEPS AND OTHER SURGICAL INSTRUMENTS. THE DEFECT UNIT AND A BLACK FRAGMENT WERE RETURNED TO (B)(4) AND VISUALLY INSPECTED: THE SEPTUM WAS FOUND TO BE DAMAGED WITH A MISSING PART THAT MATCHED THE FRAGMENT MEASURING APPROX.4.2 MM X 3.9 MM. BOTH THE DEFECT UNIT AND THE FRAGMENT WILL BE RETURNED TO AMR FOR EVALUATION. (B)(4)." PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6370646 ↗
• MalfunctionMar 1, 2017Material Fragmentation; Material Fragmentation

  LAP CHOLE- "A PIECE OF RUBBER WAS OBSERVED IN THE ABDOMEN AND REMOVED THROUGH TROCAR. SEAL WAS VISUALLY INSPECTED POST-SURGERY AND THE RUBBER INSTRUMENT SEAL SEEMED TO BE DAMAGED. ADDITIONAL PRODUCTS: VARIOUS REUSABLE INSTRUMENTS, 12MM LIGAMAX CLIP APPLIER." PATIENT STATUS: OK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6370454 ↗
• MalfunctionMar 1, 2017Material Fragmentation; Material Fragmentation

  LOW. ANTERIOR. COLON RESECTION. TATME - "NEARLY FINISHED THE PROCEDURE, THE SURGEON SAW A BLACK "RUBBER" SPOT INTRA-ABDOMINAL. NOTHING IS MISSING ON INSTRUMENTS. GUESS, IT MIGHT BE A PIECE OF A TROCAR SEAL- BUT NOT SURE." PATIENT STATUS - PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6370263 ↗
• MalfunctionMar 1, 2017Material Fragmentation; Material Fragmentation

  GASTRIC SLEEVE- "AFTER THE COMPLETION OF THE PROCEDURE THE SURGEONS FINALLY USED OUR SI SYSTEM (C6001). THEY RECOGNIZED A SMALL PIECE OF BLACK RUBBER IN THE TUBE SYSTEM. THEY INSPECTED THE KII UNIVERSAL SEALS, WHICH WERE USED DURING THE PROCEDURE, BUT THERE WAS NO VISIBLE DAMAGE OF THE SEALS. FORTUNATELY THEY COULD NOT FIND MORE PARTS IN THE ABDOMINAL CAVITY." PATIENT STATUS - OK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6370232 ↗
• MalfunctionFeb 28, 2017Break; Break

  NACH DEM CER TEIL 1 HABE ICH PERSÖNLICH DIESE CHARGE GEPRÜFT, UND LEIDER IST DIE TROKARHÜLSE BEI LEICHTEM DRUCK ZWISCHEN DAUMEN UND ZEIGEFINGER AM UNTEREN ENDE UNTER DEM BALLON GEBROCHEN. DER KUNDE MÖCHTE SOMIT AUCH DIESE TROKARE ZURÜCK SCHICKEN UND ERSATZ HABEN. DER KUNDE MÖCHTE DEN BERICHT DIREKT. TRANSLION MATTHIAS HIPPLER: AFTER THE FIRST ISSUE, DANA TESTED A STERILE PRODUCT FROM THE SAME LOT NO WITH THE SAME RESULT. WITH A SOFT PRESSURE BETWEEN THUMB AND INDEX FINGER THE DISTAL PART OF CANNULA NEAR THE BALLOON WAS BROKEN. THE CUSTOMER WANTS TO SWAP OUT THE COMPLETE STOCK OF THIS LOT NO. THE CUSTOMER IS ASKING FOR A DIRECT FULL REPORT. PATIENT STATUS - UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6365133 ↗
• MalfunctionFeb 27, 2017Break; Break

  APPEMDECTOMY - ES WURDE EIN 10MM METALLTROKAR EINGEFÜHRT. DIESE INZISION WURDE AUF 12MM ERWEITERT UND DANN EINE 12ER KII HÜLSE VON UNS ÜBER EINEN TASTSTAB EINGEBRACHT. DABEI IST DAS UNTERE TEIL DER HÜLSE UNTER DEM BALLON GEBROCHEN. EIN STÜCK WURDE GEFUNDEN, DAS 2. STÜCK, CA. 0,5 CM X 0,5 CM VERBLIEB NACH 1,5 STÜNDIGEN ERFOLGLOSEN SUCHE GGF. IN DER PATIENTIN. DANACH WURDEN DIE HÜLSEN KONTROLLIERT UND AUCH DA ZERBRACH BEI GERINGEM DRUCK DAS UNTERE TEIL UNTER DEM BALLON. DER KUNDE BITTET UM BERICHT. TRANSLATION (B)(6): THE PROCEDURE BEGAN WITH A 10MM METALLIC REUSABLE TROCAR. THEY INCREASED THE INCISION TO 12MM. WITH A 10MM FULL METAL ROD THE 12MM CANNULA WAS INSERTED INTO THE INCISION. IN THIS MOMENT THE DISTAL PART OF CANNULA, BELOW THE BALLOON, WAS BROKEN. ONE PIECE WAS FOUND, BUT THE SECOND ONE THEY CANNOT FOUND AFTER 1,5 HOUR OF SEARCHING IN THE PATIENT. MAYBE THE NOT FOUND A PIECE OF 0,5 X 0,5 CM. AFTER THE ISSUE, THEY TESTED THE DISTAL PART OF CANNULA. IT WAS BROKEN BETWEEN THUMB AND INDEX FINGER. THE CUSTOMER IS ASKING FOR A DIRECT FULL REPORT. ADDITIONAL INFO RECEIVED VIA PHONE CALL FROM AN APPLIED MEDICAL SALES REPRESENTATIVE ON FEBRUAY 1, 2017: THE PIECE IS LEFT INSIDE OF T

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 6360906 ↗
• MalfunctionJan 3, 2017Material Fragmentation; Material Fragmentation

  LAPAROSCOPIC CHOLECYSTECTOMY - "THIS IS A COMPLAINT FROM THE MARKET. ADMINISTRATIVE NO.(B)(4). PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION." REPORT FROM THE SALES REPRESENTATIVE: "THE PORTION OF THE SEPTUM CAMEL OFF ON THE FLOOR DURING A PROCEDURE. IT'S UNKNOWN WHETHER OR NOT IT CAME OFF WHILE ATTACHED TO INSTRUMENTS AFTER REMOVING THEM FROM THE TROCAR. PLEASE REFER TO THE SEPTUM CER CHECK LIST." INITIAL INVESTIGATION REPORT BY (B)(4) OLYMPUS: "THE EVENT UNIT WAS RETURNED TO OLYMPUS AND VISUALLY INSPECTED. THE FACILITY REMOVED THE DDB TO CHECK THE SEPTUM. THE SEPTUM WAS FOUND TO BE DAMAGED AND MISSING A PORTION AS SHOWN IN FIG.1. THE RETUNED SEPTUM PORTION(SIZE APPROX. 1.9MM×2.4MM, FIG. 2) MATCHED TO THE MISSING PART IN SHAPE(FIG.3). NO VISIBLE DAMAGE WAS OBSERVED WITH THE DDB AND THE SHIELD. THE UNIT WILL BE RETURNED TO (B)(4) FOR FURTHER EVALUATION. ADMIN#(B)(4)." PATIENT STATUS - "NO PATIENT INJURY".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6220361 ↗
• MalfunctionJun 8, 2016Detachment Of Device Component; Detachment Of Device Component

  LAP. SIGMARESECTION - "DISCONNECTION/DETACHMENT OF THE SEAL (SEAL-CANNULA) DURING INSTRUMENT CHANGE." PATIENT STATUS - OK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5707736 ↗
• MalfunctionJun 8, 2016Detachment Of Device Component; Detachment Of Device Component

  LAP. SIGMA-RESECTION - "DISCONNECTION / DETACHMENT OF THE SEAL (SEAL - CANNULA) DURING INSTRUMENT-CHANGE" PATIENT STATUS - "OK."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5707676 ↗
• MalfunctionJun 8, 2016Detachment Of Device Component; Detachment Of Device Component

  LAP. SIGMARESECTION - "DISCONNECTION / DETACHMENT OF THE SEAL (SEAL - CANNULA) DURING INSTRUMENT-CHANGE". PATIENT STATUS - "OK".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5707659 ↗
• MalfunctionJun 8, 2016Detachment Of Device Component; Detachment Of Device Component

  LAP. SIGMARESEKTION - "DISCONNECTION / DETACHMENT OF THE SEAL (SEAL - CANNULA) DURING INSTRUMENT-CHANGE" PATIENT STATUS - "OK".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5707639 ↗
• MalfunctionJun 1, 2016Detachment Of Device Component; Connection Problem; Detachment Of Device Component; Connection Problem

  LAPAROSCOPIC PROCEDURE - "SEAL IS FALLING OFF THE CANNULA AT MINIMAL CONTACT FORCE. LOSS OF PNEUMOPERITONEUM." PATIENT STATUS - "OK."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5693050 ↗
• MalfunctionMay 26, 2016Detachment Of Device Component; Detachment Of Device Component

  MYOMECTOMY - "SEAL DETACHES VERY EASILY FROM CANNULA. DURING GRASPER USE IN THE TROCAR (5MM REUSABLE STROZ GRASPER), SEAL DETACH FROM CANNULA. IT DETACHES EACH TIME THEY RAISE GRASPER SHAFT FROM CANNULA. THEY REPORTED IT HAPPENED ONE TIME IN THE PAST (DATA NOT AVAILABLE, DON'T REMEMBER INTERVENTION/SURGEON, NO SAMPLE AVAILABLE). NO ANY REPORT TO (B)(6). SAMPLE AVAILABLE FOR INSPECTION." PATIENT STATUS - "GOOD, NO ANY INJURY TO THE PATIENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5683947 ↗
• MalfunctionApr 4, 2016Detachment Of Device Component; Detachment Of Device Component

  PROCEDURE "NOT MENTIONED" - "WHEN THE CAMERA WAS TAKEN OUT OF THE TROCAR, THE SEAL CAME OFF THE SLEEVE. THIS HAPPENED SEVERAL TIMES SO THE DOCTOR LOST PNEUMO EVERY TIME." PATIENT STATUS - HEALTHY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5546165 ↗
• MalfunctionFeb 10, 2016Detachment Of Device Component; Detachment Of Device Component

  DA VINCI RADICAL PROSTATECTOMY - "TROCAR WAS INSERTED. AFTER REMOVAL OF THE OBTURATOR, THE CAP WITH THE SEAL SEPARATED OFF THE CANNULA. IN SEVERAL TRIALS, IT WAS NOT POSSIBLE TO ATTACH THE CAP TO THE CANNULA." PATIENT STATUS "OK."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5429206 ↗