MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SEAL FOR LAPAROSCOPE TROCAR SLEEVE; VALVE SEAL

Model Number	021299-10
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.
Event or Problem Description
It was reported that the single-use sterile valve seal was inserted into a laparoscopic trocar & cannula port as a surgical instrument for laparoscopic surgery.The scrub nurses found the valve seal was broken with a missing part after surgeons removed the cannula and returned it to the scrub nurses on the table.As the broken piece of the valve is missing.Internal reference number: (b)(4).
Additional Manufacturer Narrative
There have been returned 3 unused valve seals (sterile packed) of the same charge as the failed.The devices in question got discarded by the user.These three devices got unpacked and inspected for damages and/or material degradation and tested by a simulated use with 50 passages of an instrument through the valves.The provided unused products of the same batch didn't show any defects - even after 50 simulated penetrations - no final cause for the described failure can be determined.The most probable root cause is that a damaged instrument with a sharp edge passed the valve and damaged them during use.Internal vigilance reference number for this case is (b)(4).

• Brand Name: SEAL FOR LAPAROSCOPE TROCAR SLEEVE
• Common Device Name: VALVE SEAL
• 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: 15546317
• Report Number: 9610617-2022-00285
• Device Sequence Number: 5684642
• Product Code: GCJ
• UDI-Device Identifier: 04048551400203
• UDI-Public: 4048551400203
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K180977
• 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): 11/18/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 021299-10
• Device Catalogue Number: 021299-10
• Device Lot Number: 17/48/203
• 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: 09/19/2022
• Supplement Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 11/18/2022
• 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