MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PRECISION IDEAL EYES 10MM 30°, HD AUTOCLAVABLE LAPAROSCOPE 33CM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	0502103030
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	02/01/2018
Type of Reportable Event	Serious Injury
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 patient was burned.
Event or Problem Description
It was reported that the patient was burned.
Additional Manufacturer Narrative
Alleged failure: a burn (inflamed area) about the size of 10 mm in diameter was found out side of the thigh.Probable root cause: ¿ use error ¿ simultaneously used with hf surgical equipment.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.

• Brand Name: PRECISION IDEAL EYES 10MM 30°, HD AUTOCLAVABLE LAPAROSCOPE 33CM
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8545124
• Report Number: 0002936485-2019-00160
• Device Sequence Number: 1730531
• Product Code: GCJ
• UDI-Device Identifier: 07613327062182
• UDI-Public: 07613327062182
• Combination Product (Y/N): N
• PMA/510(K) Number: K910132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0502103030
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other