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

Catalog Number	33310ON
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	08/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product in question will be returned to the manufacturer for evaluation.
Event or Problem Description
As per manufacturer incident report #(b)(4) received from the factory in (b)(6).It was reported that there was an issue with the forceps insert.According to the complaint description, the device was used during laparoscopic case.While in use, the instrument nicked a section of the bowel, creating a small tear.
Additional Manufacturer Narrative
Based on the initial investigation, the product history did not show any deviation and the product passed the final inspection.Also, by reviewing the similar complaint and product history data, there is no indication for systematic error.
Event or Problem Description
The corresponding manufacturer's complaint reference number for this case is (b)(4).
Additional Manufacturer Narrative
Visual examination of the affected device revealed that there is no error detected and the devices function as intended.The jaw part is manufactured to avoid injuries to the patient.Furthermore, the jaw part was checked for sharp edges or any signs which can lead to an injury caused by the instrument.All edges were found to be rounded or have a chamfer.In conclusion, there is no evidence of damage to the items that would indicate a patient injury related to the device.The injury caused can thus be traced back to a handling error during application.It is assumed that the device has not been handled properly or that it has been used without proper visual control.The device quality and manufacturing history records have been checked for the available lot numbers and were found to be according to our specifications and passed the final inspection.Based on the investigation results, the root cause of the reported issue can be traced back to a usage-related failure.
Event or Problem Description
Internal karl storz reference number: (b)(4).

• Brand Name: CLICKLINE FORCEPS INSERT
• Common Device Name: LAPAROSCOPY FORCEPS
• 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 90245-5017 ; 4242188738
• MDR Report Key: 15330236
• Report Number: 9610617-2022-00254
• Device Sequence Number: 20119101
• Product Code: GCJ
• UDI-Device Identifier: 04048551134580
• UDI-Public: 4048551134580
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/28/2022

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 33310ON
• Device Lot Number: PZ5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/26/2022; 10/27/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 09/26/2022; 10/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown