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

Model Number 0502740061

Device Problem Fitting Problem (2183)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2020

Event Type  malfunction  

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 Description

It was reported that there was a surgical delay of more than 30 minutes.

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 Description

It was reported that there was a surgical delay of more than 30 minutes.

• Brand Name: PKG, SHEATH, 4.0MM OPERATIVE INNER
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10602705
• MDR Text Key: 209357431
• Report Number: 0002936485-2020-00398
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 07613327059977
• UDI-Public: 07613327059977
• Combination Product (y/n): N
• PMA/PMN Number: K040390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 09/03/2020
• Initial Date FDA Received: 09/29/2020
• Supplement Dates Manufacturer Received: 09/03/2020
• Supplement Dates FDA Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1