MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE RF 2 PROBES, LATERAL; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	0279350201
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device manufacture date is not known at this time.However, should it become available, it will be provided in future reports.Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the patient required revision surgery due to a piece still remaining inside of the patient.
Additional Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: tip of the probe broke and left inside patient probable root cause: non-conforming component.Poor assembly process.Misuse.Use error.The device manufacture date is not known.
Event or Problem Description
It was reported that the patient required revision surgery due to a piece still remaining inside of the patient.

• Brand Name: RF 2 PROBES, LATERAL
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 7844586
• Report Number: 0002936485-2018-00596
• Device Sequence Number: 11258034
• Product Code: GEI
• UDI-Device Identifier: 07613327056914
• UDI-Public: 07613327056914
• Combination Product (Y/N): N
• PMA/510(K) Number: K071859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0279350201
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 04/12/2019
• 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: Other