MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FORCEPS,MINIATURE ALLIGATOR; ALLIGATOR FORCEPS

Model Number 27071TJ

Device Problem Material Integrity Problem (2978)

Patient Problems Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)

Event Date 11/01/2020

Event Type  malfunction  

Manufacturer Narrative

We have not received confirmation from our customer if they will return the item for further evaluation.If the item returns, a supplemental report will be submitted.

Event Description

Per medwatch report # (b)(4) recieved, the grasper broke during first attempt to grasp a ureteral stent.The piece of jaw that broke off was retrieved and removed from the patient.

• Brand Name: FORCEPS,MINIATURE ALLIGATOR
• Type of Device: ALLIGATOR FORCEPS
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen ; GM
• Manufacturer Contact: susie chen ; 2151 east grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 11167610
• MDR Text Key: 229810528
• Report Number: 9610617-2021-00010
• Device Sequence Number: 1
• Product Code: OCZ
• UDI-Device Identifier: 04048551079119
• UDI-Public: 4048551079119
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27071TJ
• Device Lot Number: OP01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2020
• 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