MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, ROTATING HANDLE, INSULATED SHAFT; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Catalog Number 0250080233

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 02/09/2018

Event Type  malfunction  

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.(b)(4).

Event Description

It was reported that the insulation had been compromised.

Manufacturer Narrative

(b)(4).The device manufacture date is not known.Alleged failure: failed insulation.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could be third party repair.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 insulation had been compromised.

• Brand Name: PKG, ROTATING HANDLE, INSULATED SHAFT
• Type of Device: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• 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: ashley lower ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 7322353
• MDR Text Key: 101863459
• Report Number: 0002936485-2018-00234
• Device Sequence Number: 1
• Product Code: OCZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973259
• 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: 05/18/2018

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: Other
• Device Catalogue Number: 0250080233
• Device Lot Number: 02092018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/09/2018
• Initial Date FDA Received: 03/07/2018
• Supplement Dates Manufacturer Received: 02/09/2018
• Supplement Dates FDA Received: 05/18/2018
• 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