MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TAKE-APART FORCEPS INSERT, 5MM, 33CM

Model Number 26176HW

Device Problem Insufficient Information (3190)

Patient Problem Bowel Perforation (2668)

Event Type  Injury  

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 20-0074 corrective action 6.No product was returned.Therefore, no physical investigation can be executed.We did check the complaints for damaged or broken isolation for 26176hw working insert bipolar coagulation forceps.There are 10 comparable complaints.Each complaint was assumed to be caused due to mechanical damage and / or operator error.No indications for a systematic issue.The event is filed under internal karl storz complaint id ((b)(4)).

Event Description

It was reported that there was event with a take-apart® forceps insert.According to the information received, that during laparoscopic operation the patient's bowel was perforated, and the result was colostomy.Information about patients health was not provided.Additional patient information is not available.Date of event not known.

• Brand Name: TAKE-APART FORCEPS INSERT, 5MM, 33CM
• Type of Device: TAKE-APART FORCEPS INSERT, 5MM, 33CM
• 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: 17210113
• MDR Text Key: 317987203
• Report Number: 9610617-2023-00819
• Device Sequence Number: 1
• Product Code: HET
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K953809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26176HW
• Device Catalogue Number: 26176HW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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