MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC BOM 7MM EXTENDED LENGTH ENDOSCOPE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number C-VH-1111

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 04/03/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.

Event Description

The hospital reported that during sterilization/sanitization for an endoscopic vein harvesting procedure, bom 7mm extended length endoscope was missing an adapter piece for the light cord.They found a piece to use that they had in their facility.They noticed that the screen went dark at different times and asked the acct mgr to come and review the scope and see if getinge had any adapters they could provide for them.No patient involvement.

Manufacturer Narrative

(b)(4).

Event Description

The hospital reported that during sterilization/sanitization for an endoscopic vein harvesting procedure, bom 7mm extended length endoscope was missing an adapter piece for the light cord.They found a piece to use that they had in their facility.They noticed that the screen went dark at different times and asked the acct mgr to come and review the scope and see if getinge had any adapters they could provide for them.No patient involvement.

• Brand Name: BOM 7MM EXTENDED LENGTH ENDOSCOPE
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 8559840
• MDR Text Key: 143554365
• Report Number: 2242352-2019-00488
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K014250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/26/2019

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: Health Professional
• Device Catalogue Number: C-VH-1111
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/04/2019
• Initial Date FDA Received: 04/29/2019
• Supplement Dates Manufacturer Received: 06/21/2019
• Supplement Dates FDA Received: 07/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1