MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FOREIGN BODY FORCEPS, 28 CM

Model Number 27071TJ

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 04/10/2018

Event Type  Injury  

Event Description

It was reported that there was event with a foreign body forceps, 28 cm.According to the information received, during jj probe removal with a specific forceps, this forceps broke.The patient had a wound of urethra with bleeding requesting bladder catherization for 24 hours.Additional patient information is not available.

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.The complaint records have been analyzed for similar cases.149 similar failure description in relation to a consumption of 11.867 units were found.Thereof 3 complaints as potential incidents but after evaluation not reportable.In the vast majority of cases the forceps broke due to mechanical impact e.G.Overload caused by the operator.No indications for a product related issue.The event is filed under internal karl storz complaint id (b)(4).

• Brand Name: FOREIGN BODY FORCEPS, 28 CM
• Type of Device: FOREIGN BODY FORCEPS, 28 CM
• 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: 17079694
• MDR Text Key: 316794208
• Report Number: 9610617-2023-00910
• Device Sequence Number: 1
• Product Code: OCZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K950434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27071TJ
• Device Catalogue Number: 27071TJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2018
• 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