MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 20CM IM DISP BAYONET 0.5MM TIP; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES

Catalog Number	6770200005
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting device return.
Event or Problem Description
It was reported that during a surgical procedure, the bi-polar forceps was difficult to coagulate.It was also reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
The quality investigation is complete.Device discarded.
Event or Problem Description
It was reported that during a surgical procedure, the bi-polar forceps was difficult to coagulate.It was also reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: 20CM IM DISP BAYONET 0.5MM TIP
• Common Device Name: ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 12495873
• Report Number: 0001811755-2021-00792
• Device Sequence Number: 14296148
• Product Code: GEI
• UDI-Device Identifier: 37613327300186
• UDI-Public: 37613327300186
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110924
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2021

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: Health Professional
• Device Expiration Date: 05/15/2023
• Device Catalogue Number: 6770200005
• Device Lot Number: M0030308
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1