MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE SHEATH, STRYKEPROBE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 0250070460

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/08/2018

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.(b)(4).

Event Description

It was reported that the insulation was compromised.

Manufacturer Narrative

Alleged failure: inner yellow insulation has melted which caused the outer sheath to melt.The failure identified in the investigation is consistent with the complaint record.The probable root causes could be conductive irrigating or aspirating fluid used was inside the distal end, and contacted the probe and the sheath causing the sheath to melt, power set too high.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.(b)(4).The device manufacturer date is not known.

Event Description

It was reported that the insulation was compromised.

• Brand Name: SHEATH, STRYKEPROBE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 7392827
• MDR Text Key: 104417855
• Report Number: 0002936485-2018-00307
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K963765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/12/2018

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: 0250070460
• Device Lot Number: 041216-07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Initial Date Manufacturer Received: 03/08/2018
• Initial Date FDA Received: 04/03/2018
• Supplement Dates Manufacturer Received: 03/08/2018
• Supplement Dates FDA Received: 11/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1