MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE UNKNOWN_ENDOSCOPY_PRODUCT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	UNK_END
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device manufacturer 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
Multiple attempts were made for additional information, however no information was received.It was reported that the device malfunctioned resulting in injury to 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: patient injury.Probable root cause: poor insulation on receptacle board, manufacturing error, use error: console is sterilized or disinfected, use error: console cleaned with incompatible products.The device manufacture date is not known.
Event or Problem Description
Multiple attempts were made for additional information, however no information was received.It was reported that the device malfunctioned resulting in injury to the patient.

• Brand Name: UNKNOWN_ENDOSCOPY_PRODUCT
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8817828
• Report Number: 0002936485-2019-00306
• Device Sequence Number: 18918153
• Product Code: GEI
• UDI-Device Identifier: 07613327058086
• UDI-Public: 07613327058086
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2019

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: UNK_END
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/28/2019
• Supplement Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 09/13/2019
• 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