AESCULAP
Report
- Report Number
- 2916714-2025-00064
- Event Type
- Injury
- Date Received
- September 16, 2025
- Date of Event
- September 4, 2025
- Report Date
- October 9, 2025
- Manufacturer
- AESCULAP AG
- Product Code
- GIE
- UDI-DI
- 04038653183555
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). INVESTIGATION RESULTS: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONALLY, NO ON-SITE EVALUATION OF THE UNIT WAS PERFORMED AND NO PARTS WERE RETURNED FOR FAILURE ANALYSIS. THEREFORE, THE INVESTIGATION WAS NOT ABLE TO CONFIRM A DEVICE ISSUE THAT COULD BE ASSOCIATED WITH THE REPORTED EVENT. BATCH HISTORY REVIEW: THE DEVICE HISTORY RECORDS (DHR) WERE NOT ABLE TO BE REVIEWED AS NO LOT NUMBER WAS MADE AVAILABLE. HOWEVER, ALL DEVICE HISTORY RECORDS (DHR) ARE REVIEWED AND RELEASED ACCORDING TO DOCUMENTED PROCEDURES AND A DEVICE IS NOT RELEASED IF IT DOES NOT MEET REQUIREMENTS OR IS NONCONFORMING. CONCLUSION AND MEASURES / PREVENTATIVE MEASURES: A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.
THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). INVESTIGATION ON-GOING. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.
ACCORDING TO THE EVENT DESCRIPTION DURING A LAP CHOLE RESECTION A SCISSOR PIN FELL OUT DURING SURGERY INTO THE PATIENT AND WAS NOT LOCATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2673653 | AESCULAP | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES, | GIE | AESCULAP AG | PM697R | 04038653183555 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |