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 Consequences Or Impact To Patient (2199)

Event Date 12/30/2016

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 the device broke inside the patient.The area was irrigated and suctioned to ensure any broken pieces were removed from the patient.There were no adverse consequences.

Manufacturer Narrative

(b)(4).The device manufacture date is not known.Alleged failure: the grasper snapped inside the patient.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be excessive force applied by user.The product was returned for investigation and the failure mode was confirmed and will be monitored for future reoccurrence.

Event Description

It was reported that the device broke inside the patient.The area was irrigated and suctioned to ensure any broken pieces were removed from the patient.There were no adverse consequences.

• 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: victoria milich ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 6276665
• MDR Text Key: 66014743
• Report Number: 0002936485-2017-00068
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• 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: 1445337I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/30/2016
• Initial Date FDA Received: 01/25/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/08/2017
• 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