MAUDE Adverse Event Report: KARL STORZ SE & CO. KG METAL OUTER SHEATH, INSULATED, 36 CM

Model Number	33300
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The initial report for this event was reported to the fda on time, however the importer report was accidently not submitted with the initial.We apologize for the late reporting of this importer report.The item in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported on may 18, 2024 that during a laparoscopic appendicectomy case, the bits from the inside of sheath of a surgical instrument [ yohan] from tray accidently fell off and broke into the patient abdomen.It was noticed immediately as it broke into two pieces.It was retrieved back immediately and to re-confirm, an x-ray was taken at the end of surgery before closure, no bits were found inside and the whole team was happy.

• Brand Name: METAL OUTER SHEATH, INSULATED, 36 CM
• Common Device Name: METAL OUTER SHEATH
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 19703251
• Report Number: 2020550-2024-00172
• Device Sequence Number: 17057271
• Product Code: GCJ
• UDI-Device Identifier: 04048551002308
• UDI-Public: 4048551002308
• 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: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2024
• Report Date (Section F): 05/29/2024

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: 33300
• Device Catalogue Number: 33300
• Device Lot Number: DE37
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/14/2024
• Event Location: Hospital
• Date Report to Manufacturer: 05/29/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2024
• 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
• Patient Sex: Unknown