INZII RETRIEVAL SYSTEM
Report
- Report Number
- 2027111-2024-00931
- Event Type
- Malfunction
- Date Received
- November 27, 2024
- Date of Event
- October 23, 2024
- Report Date
- March 7, 2025
- Manufacturer
- APPLIED MEDICAL RESOURCES
- Product Code
- GCJ
- UDI-DI
- 00607915117382
- PMA / PMN Number
- K060051
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- 501
Narratives
THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. HOWEVER, A PHOTO OF THE EVENT UNIT WAS PROVIDED. VISUAL INSPECTION CONFIRMED THE COMPLAINANT¿S EXPERIENCE OF COMPONENT SEPARATION. BASED ON THE DESCRIPTION OF THE EVENT AND THE PHOTO PROVIDED, IT IS POSSIBLE THAT THE USER ATTEMPTED TO FREE THE BAG FROM THE TUBE BY PULLING THE BAG AWAY WITH A CONSIDERABLE AMOUNT OF FORCE AND IN A MANNER INCONSISTENT WITH NORMAL USAGE. IT IS ALSO POSSIBLE THAT THE SUPPORT THAT SEPARATED CONTAINED DAMAGES OR NONCONFORMANCES, LEADING TO COMPONENT SEPARATION. HOWEVER, THE EXACT ROOT CAUSE OF THE COMPONENT SEPARATION IS UNKNOWN. APPLIED MEDICAL HAS PERFORMED A HISTORICAL TREND ANALYSIS AND REVIEW OF PRODUCTION RECORDS AND NO RELEVANT DOCUMENTATION WAS IDENTIFIED. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL.
NO PRODUCT IS BEING RETURNED TO APPLIED MEDICAL FOR EVALUATION, BUT LOT NUMBER IS PROVIDED. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.
PROCEDURE PERFORMED: APPENDECTOMY. EVENT DESCRIPTION: AI TRANSLATION: WE HAVE RECEIVED A NOTIFICATION FROM [NAME] (SUPERVISOR OF MATERIAL RESOURCES, CONTACT: ) IN THE [AGENCY], THROUGH THE SURVEILLANCE CONTACT POINT OF THE [NAME], REGARDING AN INCIDENT WITH THE MEDICAL DEVICE LAPAROSCOPIC SPECIMENS COLLECTION BAG WITH THE TRADE NAME ENDOSCOPIC POUCH: [NAME] REGARDING AN INCIDENT WITH THE MEDICAL DEVICE LAPAROSCOPIC SPECIMENS COLLECTION BAG WITH THE TRADE NAME ENDOSCOPIC POUCH, MODEL INZII RETRIEVAL SYSTEM, LOT 1526944, MANUFACTURED BY APPLIED MEDICAL RESOURCES CORP, OCCURRED ON 23/10/2024, AT THE HOSPITAL [NAME]. THIS PRODUCT IS INDICATED FOR THE RECOVERY OF TISSUES, ORGANS AND STONES DURING LAPAROSCOPIC SURGERY. THE INFORMATION PROVIDED BY THE MEDICAL PROFESSIONAL IS AS FOLLOWS: DESCRIPTION OF THE INCIDENT: IN AN APPENDECTOMY INTERVENTION, WHEN TRYING TO REMOVE THE ENDOSCOPIC BAG WITH THE SAMPLE, IT IS OBSERVED THAT THE METALLIC CERCLAGE THAT SURROUNDS IT BREAKS AND COMES OUT AND REMAINS INSIDE THE PATIENT. ATTACHED IS AN IMAGE OF THE DEVICE INVOLVED IN THE INCIDENT. THE MATERIAL IS REMOVED WITHOUT INCIDENT. PATIENT RECOVERED WITHOUT SEQUELAE. ADDITIONAL INFORMATION RECEIVED FROM COMPANY REP. VIA PCF ON 08NOV24: DURING AN APPENDECTOMY PROCEDURE, WHEN CLOSING THE BAG TO REMOVE THE SPECIMEN, THE METAL ARCH DETACHES. THE SURGEON RECOVERS THE METAL ARCH, EXTRACTS IT AND NO INCIDENT OCCURS. THE SURGEON RECOVERS THE METAL ARCH, EXTRACTS IT AND NO INCIDENT OCCURS. GRASPER TO INTRODUCE THE SPECIMEN INTO THE BAG. PATIENT STATUS IS FAVORABLE. ADDITIONAL INFORMATION RECEIVED FROM COMPANY REP. VIA EMAIL ON 08NOV24: THE BEAD FELL AND THE SURGEON RECOVERED IT WITH A GRASPER AND EXTRACTED IT THROUGH A TROCAR. ADDITIONAL INFORMATION RECEIVED FROM COMPANY REP. VIA EMAIL ON 15NOV24: THE DEVICE CAME OFF WHEN THE BAG WAS CLOSED; THE CLIENT DOES NOT KNOW WHY IT COULD COME OFF AND FALL INTO THE FIELD WHEN REMOVING THE INTRODUCER. ADDITIONAL INFORMATION RECEIVED FROM COMPANY REP. VIA EMAIL ON 20NOV24: THE CLIENT INFORMS ME THAT THE SPECIMEN WAS PLACED IN THE BAG, CLOSED AND REMOVED WITHOUT ANY PROBLEM. ADDITIONAL INFORMATION RECEIVED FROM COMPANY REP. VIA EMAIL ON 22NOV24: ONLY THE METAL ROD CAME OFF. INTERVENTION: THE SURGEON RECOVERS THE METAL ARCH, EXTRACTS IT AND NO INCIDENT OCCURS. PATIENT STATUS: THE MATERIAL IS REMOVED WITHOUT INCIDENT. RECOVERED WITHOUT SEQUELAE. PATIENT STATUS IS FAVORABLE.
PROCEDURE PERFORMED: APPENDECTOMY. EVENT DESCRIPTION: AI TRANSLATION: WE HAVE RECEIVED A NOTIFICATION FROM [NAME] (SUPERVISOR OF MATERIAL RESOURCES, CONTACT:) IN THE [AGENCY], THROUGH THE SURVEILLANCE CONTACT POINT OF THE [NAME], REGARDING AN INCIDENT WITH THE MEDICAL DEVICE LAPAROSCOPIC SPECIMENS COLLECTION BAG WITH THE TRADE NAME ENDOSCOPIC POUCH: [NAME] REGARDING AN INCIDENT WITH THE MEDICAL DEVICE LAPAROSCOPIC SPECIMENS COLLECTION BAG WITH THE TRADE NAME ENDOSCOPIC POUCH, MODEL INZII RETRIEVAL SYSTEM, LOT 1526944, MANUFACTURED BY APPLIED MEDICAL RESOURCES CORP, OCCURRED ON (B)(6) 2024, AT THE HOSPITAL [NAME]. THIS PRODUCT IS INDICATED FOR THE RECOVERY OF TISSUES, ORGANS AND STONES DURING LAPAROSCOPIC SURGERY. THE INFORMATION PROVIDED BY THE MEDICAL PROFESSIONAL IS AS FOLLOWS: DESCRIPTION OF THE INCIDENT: IN AN APPENDECTOMY INTERVENTION, WHEN TRYING TO REMOVE THE ENDOSCOPIC BAG WITH THE SAMPLE, IT IS OBSERVED THAT THE METALLIC CERCLAGE THAT SURROUNDS IT BREAKS AND COMES OUT AND REMAINS INSIDE THE PATIENT. ATTACHED IS AN IMAGE OF THE DEVICE INVOLVED IN THE INCIDENT. THE MATERIAL IS REMOVED WITHOUT INCIDENT. PATIENT RECOVERED WITHOUT SEQUELAE. ADDITIONAL INFORMATION RECEIVED FROM COMPANY REP. VIA PCF ON 08NOV2024: DURING AN APPENDECTOMY PROCEDURE, WHEN CLOSING THE BAG TO REMOVE THE SPECIMEN, THE METAL ARCH DETACHES. THE SURGEON RECOVERS THE METAL ARCH, EXTRACTS IT AND NO INCIDENT OCCURS. THE SURGEON RECOVERS THE METAL ARCH, EXTRACTS IT AND NO INCIDENT OCCURS. GRASPER TO INTRODUCE THE SPECIMEN INTO THE BAG. PATIENT STATUS IS FAVORABLE. ADDITIONAL INFORMATION RECEIVED FROM COMPANY REP. VIA EMAIL ON 08NOV2024: THE BEAD FELL AND THE SURGEON RECOVERED IT WITH A GRASPER AND EXTRACTED IT THROUGH A TROCAR. ADDITIONAL INFORMATION RECEIVED FROM COMPANY REP. VIA EMAIL ON 15NOV2024: THE DEVICE CAME OFF WHEN THE BAG WAS CLOSED; THE CLIENT DOES NOT KNOW WHY IT COULD COME OFF AND FALL INTO THE FIELD WHEN REMOVING THE INTRODUCER. ADDITIONAL INFORMATION RECEIVED FROM COMPANY REP. VIA EMAIL ON 20NOV2024: THE CLIENT INFORMS ME THAT THE SPECIMEN WAS PLACED IN THE BAG, CLOSED AND REMOVED WITHOUT ANY PROBLEM. INTERVENTION: THE SURGEON RECOVERS THE METAL ARCH, EXTRACTS IT AND NO INCIDENT OCCURS. PATIENT STATUS: THE MATERIAL IS REMOVED WITHOUT INCIDENT. RECOVERED WITHOUT SEQUELAE. PATIENT STATUS IS FAVORABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 831947 | INZII RETRIEVAL SYSTEM | LAPAROSCOPE, GENERAL & PLASTIC SURGERY | GCJ | APPLIED MEDICAL RESOURCES | CD001 | 1526944 | 00607915117382 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | GRASPER |