MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE SLIDING LOCK ATRAUMATIC GRASPER, 33CM DOUBLE ACTION; FORCEPS, GENERAL & PLASTIC SURGERY

Catalog Number 0250080767

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/07/2016

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.(b)(4).

Event Description

It was reported that pin of the grasper broke off.The procedure was completed successfully.

Manufacturer Narrative

Alleged failure: crooked / bent.Confirmed failure: insert jaws are broken.Probable root cause: poor autoclave reliability, incorrect sterilization/reprocessing procedure, handling procedures, use error, shear pin failure in handle.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.The device manufacture date is not known.(b)(4).

Event Description

It was reported that pin of the grasper broke off.The procedure was completed successfully.

• Brand Name: SLIDING LOCK ATRAUMATIC GRASPER, 33CM DOUBLE ACTION
• Type of Device: FORCEPS, GENERAL & PLASTIC SURGERY
• 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: kimberly lynch ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 6087996
• MDR Text Key: 59838062
• Report Number: 0002936485-2016-01047
• Device Sequence Number: 1
• Product Code: GEN
• 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: 05/08/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 0250080767
• Device Lot Number: 1546147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/14/2016
• Initial Date FDA Received: 11/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: No
• 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