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

Model Number	33510AF
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was evaluated by the manufacturer, karl storz in (b)(4).As per the evaluation: upon evaluation it was confirmed that the rivet head was broken off.The area around the breakage surface as well as the hinge is discolored.The breakage surface itself shows dark discoloration which indicates corrosion.The device shows some scratches and usage marks; it was manufactured in may 2005.No indication for a material or manufacturing related issue was found during the investigation.The root cause most probably is wear and tear which led to corrosion and the breakage of the rivet head.Limits of reprocessing and warning to check the device after reprocessing is included in the corresponding ifu.
Event or Problem Description
Per a vigilance report received from the factory in (b)(4), allegedly, there was an event that occurred at a healthcare facility in (b)(6).The report states that intraoperative waste of the fragment (rivet head) in situ was noticed immediately and recovered from the patient.

• Brand Name: CLICKLINE GRASPING FORCEPS INSERT
• Common Device Name: GRASPING FORCEPS INSERT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 9624978
• Report Number: 9610617-2020-00006
• Device Sequence Number: 19451452
• Product Code: GCJ
• UDI-Device Identifier: 04048551150993
• UDI-Public: 4048551150993
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K935071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/23/2020

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: 33510AF
• Device Catalogue Number: 33510AF
• Device Lot Number: EE2086
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 01/23/2020
• 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: Required Intervention