MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FORCEPS, OPTICAL, STONE CRUSHING; STONE CRUSHING FORCEPS

Model Number 27074B

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/04/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation is pending return of device.

Event Description

As per an aer from (b)(6) received by the factory in (b)(6): breakage of the clamp in the patient's bladder.Extension of the intervention for recovery of the broken part.

Manufacturer Narrative

Data in section h6 have been corrected to match the evaluation findings.

Manufacturer Narrative

The complained product has been requested several times for return to execute investigation: 1st request: 07.05.2020.2nd request 14.09.2020.3rd request 21.12.2020.No product was returned.Therefore, no physical investigation can be executed.The complaint records have been analyzed for similar cases.No indications for a systematic issue was found.Warning to not leave missing or broken-off components inside the patient already included in the related ifu 2440230 v 2.1_7/2018.No harm to patient, user or third reported.No serious public health threat reported.No death or unanticipated serious deterioration in state of health reported.The potential harm within the product risk file is assessed as reversible, furthermore the occurrence is rated as negligible.Hence, the event did not and might not lead to death or serious deterioration in the stat of health.Consequently, it does not fulfil the criteria of a serious incident, according to mdr 2017/745, chapter 1, article 2, number 65 and a manufacturer incident report to the competent authority is not required.

• Brand Name: FORCEPS, OPTICAL, STONE CRUSHING
• Type of Device: STONE CRUSHING 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 e. grand avenue; el segundo, ca ; 2188201
• MDR Report Key: 10097641
• MDR Text Key: 198786688
• Report Number: 9610617-2020-00064
• Device Sequence Number: 1
• Product Code: OCZ
• UDI-Device Identifier: 04048551079386
• UDI-Public: 4048551079386
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K950434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27074B
• Device Catalogue Number: 27074B
• Date Manufacturer Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2019
• 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