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

Model Number 33310C

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2019

Event Type  malfunction  

Manufacturer Narrative

The broken instrument has not been returned for evaluation.We confirmed from the picture one of the jaws is broken.Damage is most likely due to stress overload from handling; the instrument is designed to grasp soft tissue only.The instrument had been in use for over 4 years.

Event Description

Allegedly, during a laparoscopic small bowel resection the tip of the jaw of the bowel grasper broke off inside the patient.The piece was retrieved immediately with no harm to the patient.The procedure was completed successfully with another bowel grasper.

• Brand Name: BOWEL GRASPER FORCEPS INSERT
• 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 e. grand avenue; el segundo, CA 90245 ; 4242188201
• MDR Report Key: 9474179
• MDR Text Key: 194176416
• Report Number: 9610617-2019-00117
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04048551134092
• UDI-Public: 4048551134092
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 33310C
• Device Catalogue Number: 33310C
• Device Lot Number: AU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2015
• 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: 50 YR