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 No Known Impact Or Consequence To Patient (2692)

Event Date 10/25/2017

Event Type  malfunction  

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.The top snapped, it did not remove completely, but was attached by a large portion.In order to remove it she had to remove the trocar and the instruments because the way it was snapped could not be cleanly removed.Does not believe there was any patient harm.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be excessive force, or rotational force with the jaw under load.The device manufacture date is not known.(b)(4).

Event Description

It was reported that the top of the instrument snapped.

• 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
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: roomi banerjee dua ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 7319372
• MDR Text Key: 101853565
• Report Number: 0002936485-2018-00223
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2018

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: 15401331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Initial Date Manufacturer Received: 02/06/2018
• Initial Date FDA Received: 03/06/2018
• 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 Age: 62 YR
• Patient Weight: 67