MAUDE Adverse Event Report: COLOPLAST A/S BROOKS DILATOR; SURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES)

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to the available information, during dilation of the corpora cavernosa with the brooks dilators for the implantation of a non-coloplast penile prosthesis, its head detached and became stuck at the tip of the corpus cavernosum, just behind the glans.Several trials to remove the head of the 12 mm dilator using different kinds of clamps were unsuccessful.An incision was performed to the distal lateral part of the corpora cavernosa and the head of the dilator was removed.It was noted that the corpora was moderately fibrotic due to diabetes mellitus, and dilatation was rather rigorous.Implantation was completed uneventfully.The patient was instructed to inflate the prosthesis and use it for sexual intercourse after 6 weeks.

Manufacturer Narrative

Conclusion of article: the cause of this complication, while using the dilator, was not known.Although this was noted to be a rare complication, examination of dilators prior to use was recommended, as well as cavernotome in cases in which smooth dilation is not possible.The device was not received for evaluation.Without the benefit of analyzing the device quality cannot confirm any observations or comment on the condition of the product.If the device become available, or additional information is received, the complaint will be re-evaluated according to procedures.As no lot number was provided, a review of the device history record, complaint history database, non-conformances and capas could not be completed.

• Brand Name: BROOKS DILATOR
• Type of Device: SURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES)
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9959874
• MDR Text Key: 187682734
• Report Number: 2125050-2020-00321
• Device Sequence Number: 1
• Product Code: KOA
• Combination Product (y/n): N
• PMA/PMN Number: EXCEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Type of Report: Initial,Followup
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/07/2020
• Initial Date FDA Received: 04/14/2020
• Supplement Dates Manufacturer Received: 02/07/2020
• Supplement Dates FDA Received: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR