MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH FOR 27050 SC

Model Number 27050CA

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/08/2024

Event Type  Injury  

Manufacturer Narrative

Attempts were made to obtain additional information and to have device returned for evaluation; however, there has been no response from the reporter at the time of this report.Once the evaluation is completed or if new information is received, a supplemental report would be made to the fda.This complaint will be tracked and trended.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

It was reported that the tip of inner sheath broke off during surgery.The surgeon could not retrieve the broken piece because the broken piece could not be visualized on the monitor.No additional information was provided.

• Brand Name: INNER SHEATH FOR 27050 SC
• Type of Device: INNER SHEATH FOR 27050 SC
• 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
• MDR Report Key: 18961821
• MDR Text Key: 338429092
• Report Number: 9610617-2024-00071
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2024

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
• Device Operator: Health Professional
• Device Model Number: 27050CA
• Device Catalogue Number: 27050CA
• Device Lot Number: OM06
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White