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 07/28/2017

Event Type  Injury  

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 22-0074 corrective action 6.The foreign body forceps have various bends in the shaft.The opening mechanism shows traces of excessive force application.One rivet hole is deformed to the oblong hole.One rivet is sheared off and missing.The instrument has been destroyed due to excessive force.An operator error is assumed.The event is filed under internal karl storz complaint id ((b)(4)).

Event Description

It was reported that there was event with a foreign body forceps, 28 cm.According to the information received, the instrument broke inside a patient.It is not known if the broken piece remained in patients body.Information about patients health was not provided.Additional patient information is not available.

• 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: 17290721
• MDR Text Key: 318749283
• Report Number: 9610617-2023-00908
• Device Sequence Number: 1
• Product Code: OCZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K950434
• 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: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• 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
• Device Lot Number: OX01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2012
• 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