MAUDE Adverse Event Report: STRYKER CORPORATION BABCOCK INSERT; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Model Number	0250080321
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Laparoscopic babcock broke inside patient.Team was not able to realign pieces to pull out through lap port.Instrument was pulled out of patient.Broken piece thrown away.

• Brand Name: BABCOCK INSERT
• Common Device Name: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 13583930
• Report Number: 13583930
• Device Sequence Number: 20244993
• Product Code: OCZ
• UDI-Device Identifier: 07613327058291
• UDI-Public: 07613327058291
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2022
• Report Date (Section F): 02/14/2022

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
• Device Model Number: 0250080321
• Device Catalogue Number: 0250-080-321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 02/23/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/14/2022