MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FORCEPS INSERT

Model Number	33510PG
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the consultant has used silicone pads along with berci grasping forceps during a common bile duct exploration.Consultant has removed the scope from the patient, when removing the silicone pads, one has bounced across the room and been retrieved, at this point the team are unable to locate the second.There are now concerns the second one has been lost within the abdomen.The consultant has explored laparoscopically but been unable to locate or retrieve this item.Patient was transferred to recovery stable no death or (unanticipated) serious deterioration in state of health reported.Since the location of the second pad is unclear and there is the possibility that it is still inside the patient, a report is required.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: FORCEPS INSERT
• Common Device Name: FORCEPS INSERT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 19361089
• Report Number: 2020550-2024-00148
• Device Sequence Number: 17086245
• Product Code: GCJ
• UDI-Device Identifier: 04048551151112
• UDI-Public: 4048551151112
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2024
• Report Date (Section F): 05/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 33510PG
• Device Catalogue Number: 33510PG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/17/2024
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown