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

Catalog Number 0250080767

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/10/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a piece of grasper remained inside the patient.

Event Description

It was reported that a piece of grasper remained inside the patient.

Manufacturer Narrative

Alleged failure: it was reported by the asr ryan andrews broke in patient.*update: it was not confirmed whether or not the broken pieces were retrieved.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be third party repair, poor autoclave reliability, improper sterilization or reprocessing, rough handling, or use beyond the expected use life the product was returned for investigation and the failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.

• Brand Name: PKG, SLIDING LOCK ATRAUMATIC GRASPER
• Type of Device: FORCEPS, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8214937
• MDR Text Key: 132040179
• Report Number: 0002936485-2019-00004
• Device Sequence Number: 1
• Product Code: GEN
• UDI-Device Identifier: 07613327056648
• UDI-Public: 07613327056648
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0250080767
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 01/03/2019
• Supplement Dates Manufacturer Received: 12/10/2018
• Supplement Dates FDA Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1