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
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).
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
As the device in question was not returned by the customer, a physical investigation of the product itself could not be performed.However, the available information has been reviewed.The investigation was completed on 2024-06-19.According to the information provided, item 30510px was used in conjunction with berci gripping pliers.When removing the item 30510px, the silicone pads were removed from the berci gripper and both or one of them bounced through the room due to the release.Only one silicone pad could be found in the room, the specialist performed a laparoscopic examination but could not find or retrieve the item.The operating practitioner was initially sure that he had seen both outside the abdomen after the instrument had been used but was then no longer sure.There is no indication of any failure of the silicone pads.Internal karl storz reference number: (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
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 19361088
• Report Number: 9610617-2024-00148
• Device Sequence Number: 19775540
• Product Code: GCJ
• UDI-Device Identifier: 04048551151112
• UDI-Public: 4048551151112
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K935071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 30510PX SILICONE PADS.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown