MAUDE Adverse Event Report: KARL STORZ SE & CO. KG KARL STORZ CLICKLINE FORCEPS INSERT 43CM; BOWEL GRASPER FORCEPS INSERT

Model Number	33410C
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is currently with manufacturer for further investigation; no investigation results so far.
Event or Problem Description
As per a manufacturer incident report we received from the factory in (b)(6): the main surgeon was about to move the bowel and put in the "johannes" forceps, but the instrument did not open properly; they managed to remove it from the cavity immediately.The instrument was checked by the scrub nurse, who found that the tip/head part of the "johannes" forceps was detached from the insert.The surgeon was informed.
Additional Manufacturer Narrative
Upon examination it could be confirmed that the shaft of the instrument was broken.The fracture surface shows signs of corrosion, which indicates that the instrument has not been cleaned and dried properly.The root cause probably is due to exerting too much force leading the instrument to break.No indication for a material or manufacturing related issue was found during the investigation.This issue is user handling error.There is no impact to patient/user reported, therefore this case is non-reportable.

• Brand Name: KARL STORZ CLICKLINE FORCEPS INSERT 43CM
• Common Device Name: BOWEL GRASPER FORCEPS INSERT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 10962809
• Report Number: 9610617-2020-00126
• Device Sequence Number: 14058401
• Product Code: GCJ
• UDI-Device Identifier: 04048551142875
• UDI-Public: 4048551142875
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 33410C
• Device Catalogue Number: 33410C
• Device Lot Number: WU05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2015
• Is the Device Labeled for Single Use? (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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown