MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 4.0 MM LARGE GRASPER WITHOUT RATCHET; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Catalog Number 0242040300

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 11/04/2017

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.Gtin: product obsolesced, gtin not available.

Event Description

It was reported that the arthroscopy biter broke during surgery.The broken piece then traveled posterior in the knee and was retrieved by making an additional incision.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: the jaw of a arthroscopy biter broke as a surgeon was closing the device to remove a foreign body from the knee.The broken piece traveled posterior in the knee and a open incision was made to remove the broken piece.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be normal wear or user excessive force the device manufacturer date is not known.Gtin: product obsolesced, gtin not available.

Event Description

It was reported that the arthroscopy biter broke during surgery.The broken piece then traveled posterior in the knee and was retrieved by making an additional incision.

• Brand Name: 4.0 MM LARGE GRASPER WITHOUT RATCHET
• Type of Device: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• 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: valerie estrada ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 7085774
• MDR Text Key: 93805521
• Report Number: 0002936485-2017-01177
• Device Sequence Number: 1
• Product Code: NWV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: OBSOLESCED
• 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: 04/09/2018

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: 0242040300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/08/2017
• Initial Date FDA Received: 12/05/2017
• Supplement Dates Manufacturer Received: 11/08/2017
• Supplement Dates FDA Received: 04/09/2018
• 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
• Patient Outcome(s): Other