MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., AHTO IRRIGATION PUMP; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Catalog Number	0250070601
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that kettle lead started to melt while plugged in to recharge.
Additional 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: ttle lead melting while plugged in to recharge.Confirmed failure: cosmetic, damaged rear chassis, battery failure past expiration, damaged membrane cover, damaged front panel.Probable root cause: fuse failure.Power transformer/regulator malfunction.Power supply failure.Battery charger malfunction.Incompatible rechargeable battery accessory.User error.
Event or Problem Description
It was reported that kettle lead started to melt while plugged in to recharge.

• Brand Name: PKG., AHTO IRRIGATION PUMP
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 7636138
• Report Number: 0002936485-2018-00509
• Device Sequence Number: 2412350
• Product Code: GCX
• UDI-Device Identifier: 07613327052138
• UDI-Public: 07613327052138
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K042454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2018

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
• Operator of Device: Other
• Device Catalogue Number: 0250070601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Initial Date Received by Manufacturer: 06/05/2018
• Supplement Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1