MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE KIT, FORMULA H/C SHAVER; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number 0375704500E

Device Problem Overheating of Device (1437)

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

Event Date 04/22/2018

Event Type  malfunction  

Manufacturer Narrative

The failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.The product was not received for investigation at stryker endoscopy because it was evaluated at stryker uk.The technical service report is attached (see communication log), and indicates: repair details: fault: cut in cable.Soak cap damage.(b)(6).Action taken: cable assy replaced.Tests: function test.General inspection.Electrical safety test.Pressure seal test.Qip.All tests passed.Notes: unable to replicate the running hot fault reported during testing.The reported event involving this failure and product could have been caused by: material/design error.Manufacturing/assembly error.Clogged suction path.Use error.(b)(4).

Event Description

It was reported that the device was overheating.

Event Description

It was reported that the device was overheating.

Manufacturer Narrative

The failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.The product was not received for investigation at stryker endoscopy because it was evaluated at stryker (b)(4).The technical service report is attached (see communication log), and indicates: repair details: fault: cut in cable.Soak cap damage.Action taken: cable assy replaced.Tests: function test.General inspection.Electrical safety test.Pressure seal test.Qip.All tests passed.Notes: unable to replicate the running hot fault reported during testing.The reported event involving this failure and product could have been caused by: material/design error.Manufacturing/assembly error.Clogged suction path.Use error.

• Brand Name: KIT, FORMULA H/C SHAVER
• Type of Device: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 7537889
• MDR Text Key: 109046301
• Report Number: 0002936485-2018-00451
• Device Sequence Number: 1
• Product Code: GFF
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/06/2018

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: Other
• Device Catalogue Number: 0375704500E
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/26/2018
• Initial Date FDA Received: 05/23/2018
• Supplement Dates Manufacturer Received: 04/26/2018
• Supplement Dates FDA Received: 07/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1