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

Model Number 33310C

Device Problem Material Separation (1562)

Patient Problem Unspecified Gastrointestinal Problem (4491)

Event Date 02/25/2021

Event Type  malfunction  

Manufacturer Narrative

Product has not been returned; therefore, product has not been evaluated.

Event Description

Per the facility, towards the middle of the diagnostic laparoscopy, open repair of incarcerated ventral hernia the instrument jaw broke inside the patient.The case converted to an open procedure to retrieve the broken piece and verified with x-ray.The procedure was completed with no harm to patient and no further surgical intervention.

• Brand Name: CLICKLINE INSERT,BOWEL GRASPER
• Type of Device: BOWEL GRASPER INSERT FENESTRATED
• 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: leigh spotten ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188738
• MDR Report Key: 11530664
• MDR Text Key: 241773809
• Report Number: 9610617-2021-00033
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04048551134092
• UDI-Public: 4048551134092
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K935071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 33310C
• Device Catalogue Number: 33310C
• Device Lot Number: OY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Weight: 187