EPIX® UNIVERSAL CLIP APPLIER
Report
- Report Number
- 2027111-2025-00857
- Event Type
- Malfunction
- Date Received
- November 11, 2025
- Report Date
- April 2, 2026
- Manufacturer
- APPLIED MEDICAL RESOURCES
- Product Code
- FZP
- UDI-DI
- 00607915125318
- PMA / PMN Number
- K011236
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. AS THE EVENT UNIT WAS NOT RETURNED, APPLIED MEDICAL IS UNABLE TO DETERMINE IF THE EVENT UNIT EXHIBITED ANY NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. IN THE ABSENCE OF THE EVENT UNIT, IT IS DIFFICULT TO DETERMINE IF THE REPORTED EVENT WAS CAUSED BY A MANUFACTURING NON-CONFORMANCE OR CIRCUMSTANTIAL FACTORS AT THE TIME OF USE. APPLIED MEDICAL HAS REVIEWED THE DETAILS SURROUNDING THE EVENT AND IS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE EVENT. APPLIED MEDICAL HAS PERFORMED A HISTORICAL TREND ANALYSIS AND REVIEW OF PRODUCTION RECORDS AND NO RELEVANT DOCUMENTATIONS WERE IDENTIFIED.
THE EVENT UNIT IS NOT ANTICIPATED TO RETURN TO APPLIED MEDICAL FOR EVALUATION. A FOLLOW-UP REPORT/FINAL WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.
CORRECTION TO: H6. ADVERSE EVENT PROBLEM - TYPE OF INVESTIGATION. THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. AS THE EVENT UNIT WAS NOT RETURNED, APPLIED MEDICAL IS UNABLE TO DETERMINE IF THE EVENT UNIT EXHIBITED ANY NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. IN THE ABSENCE OF THE EVENT UNIT, IT IS DIFFICULT TO DETERMINE IF THE REPORTED EVENT WAS CAUSED BY A MANUFACTURING NON-CONFORMANCE OR CIRCUMSTANTIAL FACTORS AT THE TIME OF USE. APPLIED MEDICAL HAS REVIEWED THE DETAILS SURROUNDING THE EVENT AND IS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE EVENT. APPLIED MEDICAL HAS PERFORMED A HISTORICAL TREND ANALYSIS AND REVIEW OF PRODUCTION RECORDS AND NO RELEVANT DOCUMENTATIONS WERE IDENTIFIED.
NAME OF PROCEDURE: LAPAROSCOPIC CHOLECYSTECTOMY. EVENT DESCRIPTION: TRANSLATION: WE WISH TO REPORT A QUALITY DEFECT CONCERNING A CEOLIO APPLICATOR CLIPS CLIPS UU EPIX UNIVERSAL 20 CLIPS MEDIUM LARGE REF.CA500 LOT 1547718 EXP. 14/02/2028: DURING A SURGICAL PROCEDURE, THE CLIP DID NOT EJECT FROM THE FORCEPS. THE SURGEON FELT THAT THE FORCEPS HAD JAMMED, PREVENTING ITS PROPER OPERATION AND THE EJECTION OF THE CLIP. A NEW FORCEPS WAS USED AND FUNCTIONED CORRECTLY, ALLOWING THE PROCEDURE TO CONTINUE. HOWEVER, THE PROCEDURE WAS DELAYED DUE TO THE MALFUNCTION OF THE FIRST FORCEPS. WE WOULD LIKE TO BE COMPENSATED FOLLOWING THE DISCOVERY OF THIS DEFECT. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 17NOV25: NO CLIP INSERTED INTO THE JAWS. PROBLEM WITH THE SECOND CLIP. DID NOT RECUR BECAUSE CHANGE OF CLIP CLAMP SUITE. IT HAPPENED ONCE IN THE SURGICAL FIELD AND ALSO DURING OFF-FIELD TRIALS. NOT OBSERVED WHEN CLIP WAS INSERTED AND VISIBLE BETWEEN THE JAWS OF THE DEVICE. NO LOADED CLIP BEEN MANUALLY REMOVED FROM THE JAWS. NO TRIGGER PROBLEMS. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 18NOV25: PATIENT STATUS IS UNKNOWN. YES, EVERY THING ARE ALREADY REPORTED. THE EVENT DATE IS UNKNOWN. INTERVENTION: A NEW FORCEPS WAS USED AND FUNCTIONED CORRECTLY, ALLOWING THE PROCEDURE TO CONTINUE. USING ANOTHER CLIP CLAMP. PATIENT STATUS: NO CLINICAL IMPACT TO THE PATIENT INDICATED.
NAME OF PROCEDURE: NI. EVENT DESCRIPTION: TRANSLATION: WE WISH TO REPORT A QUALITY DEFECT CONCERNING A CEOLIO APPLICATOR CLIPS UU EPIX UNIVERSAL 20 CLIPS MEDIUM LARGE REF.CA500 LOT 1547718 EXP. 14/02/2028. DURING A SURGICAL PROCEDURE, THE CLIP DID NOT EJECT FROM THE FORCEPS. THE SURGEON FELT THAT THE FORCEPS HAD JAMMED, PREVENTING ITS PROPER OPERATION AND THE EJECTION OF THE CLIP. A NEW FORCEPS WAS USED AND FUNCTIONED CORRECTLY, ALLOWING THE PROCEDURE TO CONTINUE. HOWEVER, THE PROCEDURE WAS DELAYED DUE TO THE MALFUNCTION OF THE FIRST FORCEPS. WE WOULD LIKE TO BE COMPENSATED FOLLOWING THE DISCOVERY OF THIS DEFECT. THE EVENT DATE IS UNKNOWN. INTERVENTION: A NEW FORCEPS WAS USED AND FUNCTIONED CORRECTLY, ALLOWING THE PROCEDURE TO CONTINUE. PATIENT STATUS: NO CLINICAL IMPACT TO THE PATIENT INDICATED.
NAME OF PROCEDURE: LAPAROSCOPIC CHOLECYSTECTOMY. EVENT DESCRIPTION: TRANSLATION: WE WISH TO REPORT A QUALITY DEFECT CONCERNING A CEOLIO APPLICATOR CLIPS CLIPS UU EPIX UNIVERSAL 20 CLIPS MEDIUM LARGE REF.CA500 LOT 1547718 EXP. 14/02/2028: DURING A SURGICAL PROCEDURE, THE CLIP DID NOT EJECT FROM THE FORCEPS. THE SURGEON FELT THAT THE FORCEPS HAD JAMMED, PREVENTING ITS PROPER OPERATION AND THE EJECTION OF THE CLIP. A NEW FORCEPS WAS USED AND FUNCTIONED CORRECTLY, ALLOWING THE PROCEDURE TO CONTINUE. HOWEVER, THE PROCEDURE WAS DELAYED DUE TO THE MALFUNCTION OF THE FIRST FORCEPS. WE WOULD LIKE TO BE COMPENSATED FOLLOWING THE DISCOVERY OF THIS DEFECT. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 17NOV25: NO CLIP INSERTED INTO THE JAWS. PROBLEM WITH THE SECOND CLIP. DID NOT RECUR BECAUSE CHANGE OF CLIP CLAMP SUITE. IT HAPPENED ONCE IN THE SURGICAL FIELD AND ALSO DURING OFF-FIELD TRIALS. NOT OBSERVED WHEN CLIP WAS INSERTED AND VISIBLE BETWEEN THE JAWS OF THE DEVICE. NO LOADED CLIP BEEN MANUALLY REMOVED FROM THE JAWS. NO TRIGGER PROBLEMS. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 18NOV25: PATIENT STATUS IS UNKNOWN. YES, EVERY THING ARE ALREADY REPORTED. THE EVENT DATE IS UNKNOWN. INTERVENTION: A NEW FORCEPS WAS USED AND FUNCTIONED CORRECTLY, ALLOWING THE PROCEDURE TO CONTINUE. USING ANOTHER CLIP CLAMP. PATIENT STATUS: NO CLINICAL IMPACT TO THE PATIENT INDICATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 250906 | EPIX® UNIVERSAL CLIP APPLIER | CLIP, IMPLANTABLE | FZP | APPLIED MEDICAL RESOURCES | CA500 | 1547718 | 00607915125318 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DIAMETER 5 APPLIED TROCAR |