Kii Fios First Entry CFF71Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00607915123048), received between Mar 1, 2016 and Oct 22, 2025 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (12 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2025Fracture; Fracture

  PROCEDURE PERFORMED: ABDOMINAL HISTERECTOMY. EVENT DESCRIPTION: ADDITIONAL INFORMATION PROVIDED BY DISTRIBUTOR QA COORDINATOR ON 16OCT2025: I AM CONFIRM IT¿S CFF71. THE EVENT OCCURRED DURING TREATMENT. NO PARTICLES WERE OBSERVED. ONE BROKEN FRAGMENT WAS OBSERVED. THE BEND/BREAK WAS IDENTIFIED DURING INSERTION. THE TROCAR WAS INSERTED, ROTATING ALTERNATELY CLOCKWISE AND COUNTERCLOCKWISE. YES THERE WAS DIFFICULTY DURING INSERTION. PATIENT STATUS: THE PATIENT IS IN RECOVERY WITH NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23360389 ↗
• MalfunctionDec 11, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: UNK. EVENT DESCRIPTION: APPLIED MEDICAL REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION FOR COMPLAINTS: (B)(4) (REPORT ID: 2027111-2024-00939) AND (B)(4) (REPORT ID: 2027111-2024-00940), AND REPORTED THAT THE SAME HOSPITAL, ALONG WITH THE SAME SURGEON EXPERIENCED A SIMILAR MALFUNCTION TO THE TWO COMPLAINTS MENTIONS. COMPLAINTS: (B)(4) (REPORT ID: 2027111-2024-00939) AND (B)(4) (REPORT ID: 2027111-2024-00940) MALFUNCTIONS ARE CANNULA TIP FRACTURES. IT HAPPENED TODAY ON (B)(6) 2024) AT THE SAME HOSPITAL WITH THE SAME DOCTOR. THEY THREW OUT THE PACKAGING AND THE TROCAR BUT THEY DID TAKE THIS PICTURE. THE TROCAR IS CRACKED BUT THE PIECE DIDN'T COMPLETELY FALL OFF. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20904301 ↗
• MalfunctionDec 4, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC BARIATRIC BYPASS EVENT DESCRIPTION: THE DEVICE MALFUNCTION OCCURRED WHEN REMOVING THE TROCAR. WHEN REMOVING THE TROCAR AT THE END OF THE PROCEDURE IT WAS NOTICED A PIECE WAS BROKEN OFF THE TIP OF THE CANNULA. THEY (THE SURGICAL TEAM) NOTICED IT EARLIER AND WERE ABLE TO LOCATE THE PIECE. NO PATIENT INJURY OCCURRED. THE PROCEDURE WAS COMPLETED LAPAROSCOPICALLY. THE BROKEN PIECE WAS NOTICED AT THE END WHEN PULLING OUT THE TROCAR. OTHER DEVICES USED DURING PROCEDURE: LAPAROSCOPIC INSTRUMENTS AND STAPLER. THE SURGICAL TEAM WERE ABLE TO LOCATE THE BROKEN PIECE BEFORE CLOSING SO NO PATIENT INJURY. INTERVENTION: COMPLETED THE CASE LAPAROSCOPICALLY. THE BROKEN PIECE WAS NOTICED AT THE END WHEN PULLING OUT THE TROCAR. PATIENT STATUS: THEY WERE ABLE TO LOCATE THE BROKEN PIECE BEFORE CLOSING SO NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20848989 ↗
• MalfunctionDec 4, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC DUODENAL SWITCH. EVENT DESCRIPTION: EVENT DATE: 19NOV2024, MODEL #: CFF71, LOT #: 1525891. THE DEVICE MALFUNCTION OCCURRED WHEN REMOVING THE TROCAR. WHEN REMOVING THE TROCAR AT THE END OF THE PROCEDURE IT WAS NOTICED A PIECE WAS BROKEN OFF THE TIP OF THE CANNULA. THEY (THE SURGICAL TEAM) LOOKED FOR IT BUT DID NOT FIND IT. OTHER DEVICES USED DURING PROCEDURE: LAPAROSCOPIC INSTRUMENTS AND STAPLER. ADDITIONAL INFORMATION OBTAINED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 26NOV2024. YES, CONFIRMED THE INCIDENT FROM 11/19 THEY WERE UNABLE TO LOCATE THE MISSING PIECE. INTERVENTION: SURGICAL TEAM LOOKED FOR THE BROKEN PIECE, BUT DID NOT FIND IT. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20847486 ↗
• MalfunctionJun 21, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: BARIATRIC PROCEDURE. EVENT DESCRIPTION: [HOSPITAL NAME] HAD A CASE ON (B)(6) 2024 WITH DR. [NAME] DOING A BARIATRIC PROCEDURE AND AT THE END OF THE CASE WHEN THEY REMOVED THE TROCAR, THEY NOTICED IT WAS CRACKED AT THE TIP AND A SMALL PIECE OF PLASTIC WAS MISSING. THEY DO NOT KNOW WHEN IT HAPPENED. THEY LOOKED FOR IT INSIDE THE PATIENT AND ON THE STERILE OR TABLES BUT NEVER FOUND IT. THE PATIENT WAS NOTIFIED BY THE SURGEON. NO ISSUES HAVE OCCURRED WITH THE PATIENT AT THIS POINT. THE HOSPITAL DID FILE AN INCIDENT REPORT. THE TROCAR WAS CFF71. LOT# 1497050. THE COLOR OF THE PIECE WAS CLEAR. ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL ACCOUNT MANAGER ON 19JUN2024 VIA EMAIL: A PIECE OF THE TIP OF THE TROCAR FELL OUT. NO INSTRUMENTATION WAS BEING USED AT THE TIME OF THE INCIDENT. THEY WERE REMOVING THE TROCAR AT THE END OF THE PROCEDURE. LAPAROSCOPIC INSTRUMENTS WERE USED PRIOR TO THE INCIDENT NO INTERNAL SEAL COMPONENTS WERE REMOVED OR CUT IN ORDER TO INSPECT THE DAMAGED COMPONENT. PATIENT STATUS: NO ISSUES HAVE OCCURRED WITH THE PATIENT AT THIS POINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19580145 ↗
• MalfunctionJul 8, 2020Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: BARIATRIC. EVENT DESCRIPTION: AT THE END OF THE OPERATION WHEN REMOVING THE TROCAR, IT WAS NOTICED THAT A PIECE OF PLASTIC WAS MISSING AT THE TIP OF THE SLEEVE. THIS WAS FOUND AND RECOVERED IN THE PATIENT. CUSTOMER WANTS TO RETURN THE WHOLE BOX WITH THE SAME LOT IN THE BOX IN THE BOX SYSTEM. FROM USER REPORT, RECEIVED FROM BFARM BY EMAIL ON 10JUL2020: [TRANSLATION] UPON REMOVAL OF THE TROCAR IT WAS NOTICED, THAT A PLASTIC PART OF APPROXIMATELY 1X1 CM HAD BROKEN OFF OF THE END OF THE TROCAR UNDERNEATH THE CUFF. THE PLASTIC PIECE WAS PALPATED BY THE SURGEON IN THE SURGICAL FIELD AND WAS REMOVED. AN APPROXIMATELY 1-2MM LARGE PIECE IS MISSING FROM THE BROKEN OFF PART. TYPE OF INTERVENTION: PIECE FOUND AND RECOVERED IN THE PATIENT. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10247232 ↗
• MalfunctionJan 13, 2020Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC ROBOTIC ASSISTED HYSTERECTOMY ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 08JAN2020 FROM [HOSPITAL] RISK MGMT: THE PROCEDURE BEING PERFORMED WAS A LAPAROSCOPIC ROBOTIC ASSISTED HYSTERECTOMY. THE COLOR OF THE COMPONENT WAS CLEAR. SEE PICTURE FOR WHERE FRACTURE OCCURRED. SURGEON WAS ADJUSTING TROCAR WHEN THE FRAGMENTATION OCCURRED. IT OCCURRED IMMEDIATELY AFTER REINSERTING. PIECES DID FALL INTO THE PATIENT. MISSING PIECES NEVER FOUND. NO INFORMATION TO WHAT INSTRUMENTATION WAS BEING USED AT THE TIME OF THE INCIDENT. NO INFORMATION TO HOW WAS THE PROCEDURE COMPLETED. PATIENT STATUS IS PIECES NEVER FOUND. THE DEVICE IS NOT AVAILABLE TO RETURN AS "WE DO NOT RELEASE DEFECTIVE ITEMS WHICH HAVE BEEN USED ON A PATIENT." PICTURES ARE ATTACHED. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9582546 ↗
• MalfunctionFeb 26, 2019Fracture; Fracture

  PROCEDURE PERFORMED: LAPAROSCOPIC TOTAL HYSTERECTOMY EVENT DESCRIPTION: DURING LAPAROSCOPIC TOTAL HYSTERECTOMY WITH ROBOTIC ASSIST, PATIENT WAS IN DEEP TRENDELENBURG POSITION. AS THE ROBOTIC INSTRUMENTS WERE INTRODUCED INTO THE ABDOMEN, A CRACK WAS NOTED IN THE CAMERA TROCHAR. IT WAS NOTICED DUE TO HISSING FROM LEAKING CO2. SURGEON RECOVERED THE BROKEN PIECE AND THE TROCAR WAS REMOVED. A NEW CAMERA TROCAR WAS THEN USED. NO INJURY TO PT. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 06FEB2019 FROM RISK MANAGEMENT DATA SPECIALIST: "DATE OF THE EVENT WAS (B)(6) 2018 ¿ I HAVE ADDED TO THE REPORT AND ATTACHED AGAIN. PATIENT STATUS - NO INJURY DUE TO EVENT. THE FRACTURE OCCURRED AT THE TIP. TROCAR SITES OUTLINED IN PATIENT¿S ABDOMEN, INCISIONS WERE MADE WITH SCALPEL. THE SUPRA-UMBILICAL 10/12 MM TROCAR WAS PLACED UNDER DIRECT LAPAROSCOPIC VISUALIZATION. ATRAUMATIC ENTRY WAS CONFIRMED. PNEUMOPERITONEUM WAS OBTAINED. THREE ADDITIONAL ROBOTIC TROCARS AND ONE ACCESSORY TROCAR WERE PLACED UNDER DIRECT LAPAROSCOPIC VISUALIZATION. ONE ROBOTIC TROCAR WAS PLACED ON THE RIGHT AND TWO ON THE LEFT AND THE ACCESSORY TROCAR WAS PLACED AT THE LEFT COSTAL MARGIN. AS THE ROBOTIC INSTRUMENTS WERE INTRODUCE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8372039 ↗
• MalfunctionJan 7, 2019Fracture; Fracture

  PROCEDURE PERFORMED: ROBOTIC HYSTERECTOMY. EVENT DESCRIPTION: WHILE PERFORMING A ROBOTIC HYSTERECTOMY, PROCEEDED TO DO A CUT DOWN RATHER THAN USING AN INSUFFLATION NEEDLE. INSERTED A 12MM LONG FIXATION TROCAR IN THE PATIENT, AND THEN INSUFFLATED. WHILE PLACING THE OTHER PORTS, DR. NOTICED THAT A PORTION OF THE 12MM LONG SLEEVE WAS MISSING A PIECE OF THE PLASTIC, JUST PAST THE BALLOON CUFF. AFTER THOROUGH SEARCHING, THE SMALL PLASTIC PIECE WAS LOCATED IN THE PATIENT¿S ABDOMEN AND SAFETY REMOVED. THE ENTIRE TROCAR WAS THEN REPLACED, AND WE CONTINUED WITH THE PROCEDURE. METHOD OF INSERTION WAS NORMAL TWISTING MOTION, NOT AT ALL FORCEFUL. INTERVENTION: THE SMALL PLASTIC PIECE WAS LOCATED IN THE PATIENT¿S ABDOMEN AND SAFETY REMOVED PATIENT STATUS: FINE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8224052 ↗
• MalfunctionNov 19, 2018Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: MAGENBYPASS / GASTRIC BYPASS. ORIGINAL: OP PFLEGER BERICHTET, DASS DIE TROKARHÜLSE AN DER UNTEREN ÖFFNUNG KOMPLETT ZERSPLITTERT SEIN. ER SELBST WAR BEI DEM EINGRIFF NICHT DABEI UND DER ANWENDER KONNTE BISHER NICHT BEFRAGT WERDEN. WEITERE DETAILS FOLGEN. TRANSLATION AME: OR-NURSE SAID, THAT THE CANNULAS ARE COMPLETELY SPLINTERED AT THE LOWER OPENING. HE HIMSELF WAS NOT PRESENT DURING THE SURGERY AND THE USER COULD NOT BE ASKED YET. MORE INFORMATION WILL FOLLOW. ADDITIONAL INFORMATION RECEIVED FROM SALES REPRESENTATIVE BY EMAIL ON 22OCT2018: ONLY 1 TROCAR WAS SPLINTERED. I JUST TALKED TO PROFESSOR [NAME], HE WAS THE USER WHO COMPLAINED ABOUT THE TROCAR. AT THE END OF THE SURGERY, HE WANTED TO CHANGE THE CAMERA AND NOTICED THAT THE BOTTOM OF THE SLEEVE WAS "CRUMBLED". HE HAS OPERATED AS USUAL AND HAS NOT NOTICED ANY IMPACT OF THE INSTRUMENTS AGAINST THE SLEEVE. PROFESSOR [NAME] WAS UNABLE TO DETECT ANY BROKEN PLASTIC PARTS IN THE PATIENTS ABDOMEN, BUT ASKS FOR INFORMATION IF WE FIND THAT PARTS OF THE SLEEVE ARE MISSING. ADDITIONAL INFORMATION RECEIVED FROM SALES REPRESENTATIVE BY EMAIL ON 28NOV2018: NO UNUSUAL FORCE WAS APPLIED WHEN INSERTING THE TROCAR. TYPE OF I

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8085194 ↗
• MalfunctionSep 11, 2018Material Fragmentation; Material Fragmentation

  NAME OF PROCEDURE BEING PERFORMED: DAVINCI ROBOTIC HERNIA LAP REPAIR. EVENT DESCRIPTION: DURING SURGERY A PIECE OF BLACK RUBBER SEAL WAS FOUND ON TOP OF THE BOWEL. THE SURGEON REMOVED IT. THE TOP OF THE TROCAR WAS REMOVED AND FOUND THAT THE PIECE MATCHED THE MISSING PIECE FROM THE TROCAR. THIS WAS THE PORT USED FOR THE DAVINCI SCOPE. THIS OCCURRED AT THE END OF THE CASE AND THE CASE WAS COMPLETED WITH NO PATIENT INJURY. THE DEVICE IS AVAILABLE FOR RETURN. MEDWATCH REPORT (MW5079229) RECEIVED VIA MAIL ON (B)(6) 2018: AT THE END OF ROBOTIC HERNIA REPAIR, TWO PIECES OF BLACK RUBBER NOTED ON PTS OMENTUM VISUALIZED. PHYSICIAN REMOVED AND IRRIGATED ABDOMEN TO MAKE SURE NO OTHER PIECES LEFT. BLACK RUBBER PIECES DETERMINED TO HAVE COME FROM THE BLACK SEAL FORM THE APPLIED MEDICAL TROCAR. DATES OF USE: (B)(6) 2018. DIAGNOSIS OF REASON FOR USE: ROBOTIC LAP HERNIA REPAIR. PATIENT STATUS: NO PATIENT INJURY OCCURRED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 7865175 ↗
• MalfunctionMay 26, 2017Fracture; Fracture

  PROCEDURE PERFORMED: LAP CHOLE. EVENT DESCRIPTION: TROCAR WAS BEING USED FOR THE CAMERA PORT. AT THE END OF CASE, SCRUB NOTICED A PIECE OF CANNULA MISSING FROM TIP. TYPE OF INTERVENTION: LOOKED AND LOOKED IN PATIENT BUT COULD NOT FIND IT. PATIENT STATUS: THEY SAID THERE WAS NO INITIAL INJURY TO PATIENT, BUT COULD NOT FIND PIECE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6596114 ↗
• MalfunctionMar 2, 2017Partial Blockage; Crack; Material Fragmentation; Failure to Advance

  ROBOTIC LEFT CHEST MEDIASTINAL LYMPHNODE- "UPON INSERTION OF THE CAMERA SURGEON NOTICED THE INNER LUMEN LOOKED CRACKED AROUND THE BALLOON AREA AND THAT PART OF THE TROCAR LOOKED CHIPPED AND A PIECE WAS IN THE WAY OF ALLOWING THE CAMERA TO MOVE THROUGH THE TROCAR." PATIENT STATUS: FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6372882 ↗
• MalfunctionMar 1, 2017Material Fragmentation; Material Fragmentation

  ROBOTIC LAPAROSCOPIC HYSTERECTOMY - "CASE WAS PERFORMED BY DR. (B)(6). A CFF73 TROCAR WAS USED FOR HER CAMERA PORT. DURING THE CASE A SMALL PIECE OF BLACK PLASTIC WAS OBSERVED INSIDE OF THE PATIENT'S ABDOMEN. IT WAS REMOVED FROM THE PATIENT AND APPEARED TO BE A PIECE OF THE TROCAR SEAL. VISUAL INSPECTION SHOWS THAT THE PIECE APPEARS TO HAVE BEEN TORN FROM THE SEAL, RATHER THAN CUT OR MELTED, BECAUSE IT HAS A ROUGH EDGE. THE ONLY INSTRUMENT THAT HAS PASSED THROUGH THE TROCAR WAS THE ROBOTIC CAMERA." PATIENT STATUS - AT HOME WITH NO ISSUES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6370901 ↗
• MalfunctionMar 1, 2017Fracture; Fracture

  SLEEVE GASTRECTOMY- "TROCAR HAD VERY HIGH TORQUE BEING APPLIED FROM INSTRUMENT BEING USED THROUGH THE PORT. VERY LARGE PATIENT SO ACCESS AND REACH OF INSTRUMENTS BEING USED WAS EXTREMELY LIMITED." PATIENT STATUS: PROCEDURE WENT AS PLANNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6370655 ↗
• MalfunctionFeb 21, 2017Material Fragmentation; Material Fragmentation

  DA VINCI VENTRAL HERNIA REPAIR - THE SCRUB TECH NOTICED THAT THE SEAL WAS LEAKING THROUGHOUT THE CASE AND THE INSTRUMENT EXCHANGES WERE ROUGH. AT THE END OF THE PROCEDURE THE DOCTOR DID A FINAL INSPECTION AND NOTICED THAT PART OF THE SEAL HAD FALLEN INTO THE PATIENT. IT WAS A TORN SECTION OF THE BLACK INNER SEAL AND THE DOCTOR WAS ABLE TO SAFELY REMOVE THE SECTION OF THE SEAL. THIS PORT WAS USED FOR INSTRUMENTS AND WAS USED BY BOTH THE HEALTH PROFESSIONAL AND THE ROBOT "PIGGY BACK PORT". THE ROBOT WAS A DA VINCI SI ROBOT MULTIPLE INSTRUMENTS WERE USED, BUT THE SALES REP WAS ONLY ABLE TO GET CONFIRMATION ABOUT AN L HOOK. DEVINCI SI ROBOT WAS USED. ADDITIONAL INFORMATION RECEIVED FROM SALES REPRESENTATIVE ON FEBRUARY 15, 2017: THE SALES REP SPOKE TO THE DOCTOR ABOUT THE "PIGGY BACK PORT". THE DOCTOR USED OUT CFF71 AS AN ACCESS PORT AND WOULD INSERT THE DA VINCI 8MM TROCAR WITH NO OBTURATOR INSIDE THE CFF71. TYPE OF INTERVENTION: SEAL WAS SAFELY REMOVED. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6346908 ↗
• MalfunctionJun 30, 2016Material Fragmentation; Material Fragmentation

  ROBOTIC HYSTERECTOMY - "INTERNAL COMPONENT OF THE TROCAR FELL OUT. IT WAS A BLACK RUBBER PIECE OF THE SEAL WHICH FELL INTO THE PATIENT. IT WAS THE ENTIRE PIECE THAT FELL OUT AND IT WAS RETRIEVED. PNEUMO WAS RESTABLISHED." PATIENT STATUS: "OK". ADDITIONAL INFORMATION RECEIVED - JUNE, 7 2016: WHAT INSTRUMENTS WERE INSERTED AT THE TIME OF THE INCIDENT: PASSING THE SUTURE THROUGH THE TROCAR; AT WHAT POINT IN THE PROCEDURE DID THIS OCCUR: END; WAS THERE ANY LOSS OF PNEUMO: NO; IF SO WAS IT RAPID OR GRADUAL: NO; WHAT TYPE OF PROCEDURE WAS PERFORMED: ROBOTIC HYSTERECTOMY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5763149 ↗
• MalfunctionMar 1, 2016Fracture; Fracture

  ROBOTIC ASSISTED LAPAROSCOPIC PARTIAL NEPHRECTOMY - "PATIENT HAD A RIGHT ROBOTIC ASSISTED LAPAROSCOPIC PARTIAL NEPHRECTOMY. UPON REMOVING THE TROCARS TO TAKE OUT THE SPECIMEN, ONE OF THE TROCARS (12X150MM ADVANCED FIXATION SLEEVE TROCAR) WAS NOTED TO HAVE A MISSING TIP. ALL PIECES WERE NOT ABLE TO BE RETRIEVED. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING)." PATIENT STATUS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5471630 ↗