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

Model Number	33310C
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instrument has not been returned for evaluation yet.The instrument has a date code of nx (january 2012); it has been in use for approximately 5 years and 4 months.A possible cause for breakage is stress overload.
Event or Problem Description
Allegedly, during a laparoscopic myomectomy procedure the doctor noted that both jaws broke off the instrument and fell into the patient.The doctor used another bowel grasper from another set and one of the jaws broke off as well.The doctor immediately retrieved the missing pieces using a sterile magnet.Note: this report pertains to the first instrument that broke; as separate report will be filed for the second instrument that broke.

• Brand Name: INSERT, BOWEL GRASPER
• Common Device Name: BOWEL GRASPER
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen
• MDR Report Key: 6665615
• Report Number: 9610617-2017-00047
• Device Sequence Number: 16161048
• Product Code: GCJ
• UDI-Device Identifier: 04048551069264
• UDI-Public: 4048551069264
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K935071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2017
• Report Date (Section F): 06/23/2017

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?: No
• Operator of Device: Physician
• Device Model Number: 33310C
• Device Catalogue Number: 33310C
• Was Device Available for Evaluation?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/23/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention