MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 33CM DORSEY GRASPER FORCEPS; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Catalog Number	0250080319
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device broke during procedure.The broken pieces were successfully retrieved.
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.
Additional Manufacturer Narrative
Alleged failure: the dorsey jaw broke while inside the patient.Surgeon said he was trying to pull out a mini-lap from patient and that's when the jaw broke.The broken pieces were successfully retrieved.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could be excessive force applied by user.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Added initial reporter phone number.The manufacturer date in not known.
Event or Problem Description
It was reported that the device broke during procedure.The broken pieces were successfully retrieved.

• Brand Name: 33CM DORSEY GRASPER FORCEPS
• 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: 21774504
• Report Number: 0002936485-2025-00282
• Device Sequence Number: 21247293
• Product Code: OCZ
• UDI-Device Identifier: 07613327058239
• UDI-Public: 07613327058239
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K973259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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 Catalogue Number: 0250080319
• Device Lot Number: 152099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 07/16/2025
• 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
• Patient Sex: Male