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

Catalog Number	0502539010
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
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 scope was blurry during procedure.
Additional Manufacturer Narrative
Alleged failure: blurry.Confirmed failure: outer tube damaged (bent, dented),damaged distal cover glass.Probable root cause: ¿ incorrectly assembled optical train ¿ damage to optical train ¿ end of life wear-out ¿ shipping damage ¿ use error.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.
Event or Problem Description
It was reported scope was blurry during procedure.

• Brand Name: HD 5MM 0° LAPAROSCOPE, AC
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8850960
• Report Number: 0002936485-2019-00324
• Device Sequence Number: 10837374
• Product Code: GCJ
• UDI-Device Identifier: 07613327059403
• UDI-Public: 07613327059403
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K910132
• 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): 10/11/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0502539010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2019
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 10/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1