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

Model Number 27050CA

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/12/2018

Event Type  Injury  

Event Description

It was reported that during turp + laser sheath bakelite breaks off and falls into patient bladder.Not seen during operation.Post-op x-ray done.Patient operated the day after to retrieve bakelite.Cystoscopy done the day after.It was impossible to get the bakelite out the body via natural means.A mini laparotomy was done to retrieve foreign object.

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 20-0052 corrective action 6.The ceramic tip is missing and has not been sent back.The gluing area is deformed.Glue is present and well affixed to the stainless steel in the gluing area.There are some scratches in the stainless steel tube.The sheath has most likely been hit against something rigid.This broke the gluing joint.Damages like this could be found, if the mandatory inspection before and after use would have been performed.The event is filed under internal karl storz complaint id ((b)(4)).

• 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: 16974004
• MDR Text Key: 315738071
• Report Number: 9610617-2023-00640
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K943668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2023

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: US04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2018
• Initial Date FDA Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2017
• 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