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

Model Number	0250070601
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	11/21/2019
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.
Additional Manufacturer Narrative
Alleged failure: the tower generated a warning signal on the isulation monitor, which was not recognized by the responsible sister, because she was not instructed in these signals according to her own statement.Shortly after the signal, a jet of flame occurred at the ahto (approx.10-30 seconds), causing the power cable and pump to fuse.The incident did not influence the surgical result, as the incident took place before the beginning of the surgery (the patient had just been pushed into the room).Surgical delay of 15min.Not longer.There have been no changes in the procedure of the surgery.Nobody was injured or impaired.Please see the following compoments which belong to the tower affected in this event: ref 250-070-601 sn: (b)(4).Computer sdc-hd-ref 240-050-888 sn: (b)(4).Transmitter synk wireless system sn: (b)(4).Light source x8000 sn: (b)(4).Printer sdp1000 sn: (b)(4).Monitor, tft visionelect hd sn: (b)(4).Insufflator 40 liter sn: (b)(4).Camera processor 1188hd sn: (b)(4).Camera head 1188210105 sn: (b)(4).The failure(s) identified in the investigation is consistent with the complaint record.Probable root causes could be the pump's ac inlet got some fluid ingress (ex.Saline, cleaning chemical) causing short circuit on the ac inlet.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.

• 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: 9403724
• Report Number: 0002936485-2019-00533
• Device Sequence Number: 10909060
• Product Code: GCX
• UDI-Device Identifier: 07613327052138
• UDI-Public: 07613327052138
• Combination Product (Y/N): N
• PMA/510(K) Number: K042454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

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 Model Number: 0250070601
• Device Catalogue Number: 0250070601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1