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

Model Number 0250070601

Device Problems Thermal Decomposition of Device (1071); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Date 11/21/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event Description

It was reported that there was a thermal event.

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 Description

It was reported that there was a thermal event.

• Brand Name: PKG., AHTO IRRIGATION PUMP
• Type of Device: 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
• MDR Text Key: 176096543
• Report Number: 0002936485-2019-00533
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 07613327052138
• UDI-Public: 07613327052138
• Combination Product (y/n): N
• PMA/PMN Number: K042454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1