MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, SHEATH, 4.0MM OPERATIVE INNER; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number	0502740061
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that there was a surgical delay of more than 30 minutes.
Additional Manufacturer Narrative
Alleged failure: 0502740062 - lack of internal gasket - lost.0502740061 - according to the protocol from the visit to the hospital, there was an obstruction of the tool canal and a mechanical damage, breaking the optics mounting assembly from the optics cladding.0233032880 - efficient.Equipment is at ous stryker facility - to be sent for evaluation the failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root causes could a damaged outer sheath the product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported that there was a surgical delay of more than 30 minutes.

• Brand Name: PKG, SHEATH, 4.0MM OPERATIVE INNER
• Common Device Name: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10602705
• Report Number: 0002936485-2020-00398
• Device Sequence Number: 1178707
• Product Code: FAS
• UDI-Device Identifier: 07613327059977
• UDI-Public: 07613327059977
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K040390
• 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): 11/13/2020

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 Model Number: 0502740061
• Device Catalogue Number: 0502740061
• Device Lot Number: 1457084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1