MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE HD 10MM 0A LAPAROSCOPE, AC; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	0502859010
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer 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 the moisture could not be wiped from the scope.File malfunction due to unclear image.
Additional Manufacturer Narrative
Alleged failure: crack on edge of lens that fogs up operatively confirmed failure: outer tube damaged (bent, dented), moisture ingression at distal end, loose optical system.Probable root cause: thermal destruction of epoxy improper epoxy/curing process laser welding failure use error furthermore, reportability decision was check for consistency.Manufacture date is not known.
Event or Problem Description
It was reported that the moisture could not be wiped from the scope.File malfunction due to unclear image.

• Brand Name: HD 10MM 0A 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: 9665246
• Report Number: 0002936485-2020-00050
• Device Sequence Number: 688414
• Product Code: GCJ
• UDI-Device Identifier: 07613327060294
• UDI-Public: 07613327060294
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/10/2020

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: 0502859010
• Device Catalogue Number: 0502859010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1