MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 5MM PEEK HANDLE, 45CM; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Model Number	0250181164
Health Effect - Clinical Code	Blister (4537)
Date of Event	07/26/2021
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 that product arced resulting in blisters to the patient's skin.
Additional Manufacturer Narrative
The product was not returned for investigation and the reported failure mode was not confirmed.Alleged failure: arcing.The probable root causes could be user misuse, excessive force, normal wear, or improper sterilization methods.The device manufacture date is not known.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that product arced resulting in blisters to the patient's skin.

• Brand Name: PKG, 5MM PEEK HANDLE, 45CM
• Common Device Name: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 12558407
• Report Number: 0002936485-2021-00527
• Device Sequence Number: 1416197
• Product Code: OCZ
• UDI-Device Identifier: 07613327056716
• UDI-Public: 07613327056716
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K973259
• 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): 12/22/2021

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 Model Number: 0250181164
• Device Catalogue Number: 0250181164
• Device Lot Number: 1840833K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown