MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE HD 5MM 0° LAPAROSCOPE, AC; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number 0502539010

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/15/2019

Event Type  malfunction  

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 Description

It was reported the scope had a cloudy image during use, procedure completed successfully with a replacement scope.

Manufacturer Narrative

Alleged failure: cloudy.Probable root cause: ¿ laser welding seal failure ¿ distal/proximal window solder failure ¿ damage to optical train ¿ damage to needle ¿ damage to distal or proximal windows ¿ moisture intrusion ¿ end of life wear-out ¿ environmental disturbance: endoscope colder than dew point ¿ environmental disturbance: fluid entrapment between the coupler and eyepiece junction (eyepiece only) ¿ use error the product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.

Event Description

It was reported the scope had a cloudy image during use, procedure completed successfully with a replacement scope.

• Brand Name: HD 5MM 0° LAPAROSCOPE, AC
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8608027
• MDR Text Key: 145095183
• Report Number: 0002936485-2019-00204
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 07613327059403
• UDI-Public: 07613327059403
• Combination Product (y/n): N
• PMA/PMN Number: K910132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/12/2019

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 Catalogue Number: 0502539010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/15/2019
• Initial Date FDA Received: 05/14/2019
• Supplement Dates Manufacturer Received: 04/15/2019
• Supplement Dates FDA Received: 08/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1