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	09/12/2018
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 there was a thermal event.There was no associated procedure and no reports of adverse consequences.
Additional Manufacturer Narrative
Alleged failure: the customer reported that after installing the battery, the device was put on charge.After a few minutes smoke began to come out of the device.It was quickly disconnected.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be a possible power surge via power connection to the unit and/or an incorrect connection configuration between the battery and the unit.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that there was a thermal event.There was no associated procedure and no reports of adverse consequences.

• 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: 7931287
• Report Number: 0002936485-2018-00630
• Device Sequence Number: 11209399
• Product Code: GCX
• UDI-Device Identifier: 07613327052138
• UDI-Public: 07613327052138
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K042454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2018

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
• Device Lot Number: 18G518104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1