MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INSERT,BOWEL GRASPER,FENESTRAT

Model Number 33310C

Device Problem Defective Device (2588)

Patient Problems Injury (2348); Patient Problem/Medical Problem (2688)

Event Date 03/07/2020

Event Type  malfunction  

Manufacturer Narrative

Product has not returned to karl storz (b)(4) for further review and the date code was not provided.

Event Description

Per the factory in (b)(6), allegedly there was an event which occurred in (b)(6) that during the surgical procedure of laparoscopic appendectomy, the clamp in normal manipulations was malfunctioning causing a gastrointestinal injury.

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: 1 st request: 01.04.2020 2nd request 14.09.2020 3rd request 21.12.2020 no product was returned.Therefore, no physical investigation can be executed.The malfunction could be caused by overloading the instrument by exerting too much force.However, this cannot be confirmed because the instrument could not be examined.Based on this, there is no indication for a systematic issue, on the basis of which no further action is required.

• Brand Name: INSERT,BOWEL GRASPER,FENESTRAT
• Type of Device: BOWEL GRASPER
• 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 ; 2188201
• MDR Report Key: 9935952
• MDR Text Key: 188080874
• Report Number: 9610617-2020-00047
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04048551134092
• UDI-Public: 4048551134092
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K935071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 33310C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2020
• Initial Date FDA Received: 04/08/2020
• Supplement Dates Manufacturer Received: 03/07/2020; 03/07/2020
• Supplement Dates FDA Received: 08/09/2022; 08/11/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 26 YR