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
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
The affected device has been requested for investigation by the manufacturer.
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: 15546133
• Report Number: 9610617-2022-00286
• Device Sequence Number: 6575807
• 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