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

Model Number 0250080767

Device Problem Break (1069)

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

Event Date 10/04/2019

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 plastic sheath on wave grasper broke intraoperatively, all pieces were retrieved and the procedure was completed successfully.

Manufacturer Narrative

Alleged failure: black, plastic sheath on wave grasper broke intraoperatively, small pieces of plastic were removed laparoscopically and patients abdomen was throughly examined for foreign pieces of plastic.Salesforce case number (b)(4).The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be user misuse, excessive force, normal wear, or improper sterilization methods.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.

Event Description

It was reported that the plastic sheath on wave grasper broke intraoperatively, all pieces were retrieved and the procedure was completed successfully.

• 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: 9251636
• MDR Text Key: 173925716
• Report Number: 0002936485-2019-00483
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 02/20/2020

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 Model Number: 0250080767
• Device Catalogue Number: 0250080767
• Device Lot Number: 17416881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Initial Date Manufacturer Received: 10/04/2019
• Initial Date FDA Received: 10/29/2019
• Supplement Dates Manufacturer Received: 10/04/2019
• Supplement Dates FDA Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1