MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY CLICKLINE ROTHENBERG BOWEL GRASPER

Model Number	31310C
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We evaluated the device.Both jaws had broken off; one during procedure and one when doctor removed the device and was handling.Possible cause is stress overload due to retracting or lifting heavy tissue which our ifu warns against.
Event or Problem Description
Allegedly, the doctor was performing a mini lap appendectomy when he noted that one of the jaws broke off into patient.He immediately retrieved broken jaw and went on to complete procedure.The hospital reports there was no injury to the patient.

• Brand Name: CLICKLINE ROTHENBERG BOWEL GRASPER
• Common Device Name: BOWEL GRASPER
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen, germany, ; GM
• MDR Report Key: 6659236
• Report Number: 9610617-2017-00045
• Device Sequence Number: 1149926
• Product Code: GCJ
• UDI-Device Identifier: 04048551333723
• UDI-Public: 4048551333723
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K935071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 31310C
• Device Catalogue Number: 31310C
• Device Lot Number: PU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2017
• Initial Report FDA Received Date: 06/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 82