MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE BIG DOG SUTURE CUTTER; CUTTER, WIRE

Model Number 0234102102

Device Problem Break (1069)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2022

Event Type  malfunction  

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 the device broke during the procedure.All pieces were retrieved.

Event Description

It was reported that the device broke during the procedure.All pieces were retrieved.

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: instrument broken probable root cause: design: poor mechanical advantage design inadequate material selection for cutter (distal or proximal features) distal assembly of cutter susceptible to fragmentation break away pin too weak excessive interference between jaw and shaft (big dog only) process: inadequate assembly of cutter cutting edge inadvertently dulled during manufacturing use error the reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.

• Brand Name: BIG DOG SUTURE CUTTER
• Type of Device: CUTTER, WIRE
• 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: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 13827294
• MDR Text Key: 293837574
• Report Number: 0002936485-2022-00128
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 07613327173451
• UDI-Public: 07613327173451
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0234102102
• Device Catalogue Number: 0234102102
• Device Lot Number: 62336
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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