MAUDE Adverse Event Report: KARL STORZ SE & CO. KG STONE CRUSHING FORCEPS, SGL. ACTION JAWS

Model Number 27074B

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 09/27/2017

Event Type  Injury  

Event Description

It was reported that there was event with a stone crushing forceps, sgl.Action jaws.According to the information received, during manual lithotripsy for bladder stone case, mobile jaw broke.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.The movable jaw is broken on both hinge sides.The fracture surfaces show the typical appearance of an overload fracture and are located at the point expected for a mechanical overload.The event is filed under internal karl storz complaint id (b)(4).

• Brand Name: STONE CRUSHING FORCEPS, SGL. ACTION JAWS
• Type of Device: STONE CRUSHING FORCEPS, SGL. ACTION JAWS
• 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: 17079695
• MDR Text Key: 316694344
• Report Number: 9610617-2023-00912
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/07/2023

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: 27074B
• Device Catalogue Number: 27074B
• Device Lot Number: WT01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2016
• 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