MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Model Number 0250080234

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/26/2020

Event Type  Injury  

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 Description

It was reported that a piece was potentially left inside the patient.It was not confirmed whether small fragments remained within the patient.

Manufacturer Narrative

This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: grasper broke.Probable root cause: patient anatomy, portal location, incorrect instrument diameter/length, manufacturing/ servicing error, use error.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.

Event Description

It was reported that a piece was potentially left inside the patient.It was not confirmed whether small fragments remained within the patient.

• Brand Name: PKG, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT
• Type of Device: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10180017
• MDR Text Key: 195983473
• Report Number: 0002936485-2020-00239
• Device Sequence Number: 1
• Product Code: OCZ
• UDI-Device Identifier: 07613327052473
• UDI-Public: 07613327052473
• Combination Product (y/n): N
• PMA/PMN Number: K973259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0250080234
• Device Catalogue Number: 0250080234
• Device Lot Number: 14403520
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other