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 06/10/2015

Event Type  malfunction  

Event Description

It was reported that the tip and screw broke off into the patient; however, everything was recovered and the case was completed.

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Manufacturer Narrative

The product was returned and the failure mode was confirmed.During the inspection of the sliding lock atraumatic grasper, 33cm double action, dings and scratches were seen throughout the entire unit.Also it was confirmed the articulating jaw hinge is disconnected from the drive shaft.The hinge pin is broken of the hinge and was received with the unit.The probable root cause/s could be due to user excessive force and or mishandling.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.

Event Description

It was reported that the tip and screw broke off into the patient; however, everything was recovered and the case was completed.

• 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: 4888428
• MDR Text Key: 6018156
• Report Number: 0002936485-2015-00577
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/10/2015

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: 1242148G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/10/2015
• Initial Date FDA Received: 07/02/2015
• 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