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

Model Number 0250181164

Device Problem Arcing (2583)

Patient Problem Blister (4537)

Event Date 07/26/2021

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 that product arced resulting in blisters to the patient's skin.

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 Description

It was reported that product arced resulting in blisters to the patient's skin.

• Brand Name: PKG, 5MM PEEK HANDLE, 45CM
• Type of Device: 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
• MDR Text Key: 274221055
• Report Number: 0002936485-2021-00527
• Device Sequence Number: 1
• Product Code: OCZ
• UDI-Device Identifier: 07613327056716
• UDI-Public: 07613327056716
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other