MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ROBI KELLY FORCEPS INSERT; RIGID ENDOSCOPIC TISSUE MANIPULATION FO

Model Number 38610MD

Device Problem Temperature Problem (3022)

Patient Problem Insufficient Information (4580)

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 22-0074 corrective action 6.The event is filed under internal karl storz complaint id (b)(4).The complained product has been requested several times for return to execute investigation: 1st request: 16.07.2019.2nd request 09.04.2020.3rd request 11.09.2020.No product was returned.Therefore, no physical investigation can be executed.Date of manufacture lot code "tu32" is june 2015.The complaint records have been analyzed for similar cases.Similar cases were found.Most of them had thermal damages caused by either residual due to erroneous reprocessing or over voltage during application.Therefore, the potential root cause is assumed as either overvoltage which caused high temperature or there was residual tissue between the joint area of the forceps which could lead to short circuit and thus to heat generation.No indications for a systematic issue.

Event Description

It was reported that there was event with a "forceps insert".According to the information received, during laparoscopy, when coagulating with roby forceps, the plastic part melt with production of smoke.Further information is not available.

• Brand Name: ROBI KELLY FORCEPS INSERT
• Type of Device: RIGID ENDOSCOPIC TISSUE MANIPULATION FO
• 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: 17200530
• MDR Text Key: 318229629
• Report Number: 9610617-2023-00799
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K962030
• 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: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 38610MD
• Device Catalogue Number: 38610MD
• Device Lot Number: TU32
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/15/2015
• 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
• Treatment: 38151 ROBI PLASTIC HANDLE; 38600 ROBI METAL OUTER SHEATH